News for the ‘Medical Devices’ Category

Cold Therapy Lawsuits

Cold Therapy Machines Under Investigation

Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:

  • DonJoy Cold Therapy Machines
  • PolarCare Cold Therapy Machines
  • EBIce Cold Therapy Machines

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

Cold Therapy Attorney

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.

Cold Therapy DonjoyProlonged exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment may cause skin damage, permanent nerve damage, and chronic pain to patients. A case report entitled, Cryotherapy Can Cause Permanent Nerve Damage, was published in the American Journal of Pain Management in April of 2004. The case study describes the cold therapy side effects of a patient who had undergone repetitive and prolonged cryotherapy (application of ice), and cryosurgery (cryoablation).

Cold Therapy Side Effects

Cold therapy side effects may include one or more of the following:

  • Skin damage
  • Nerve damage
  • Wrist, ankle, shoulder or back injury
  • Hand amputation
  • Foot amputation
  • Loss of a limb
    • Arm amputation
    • Leg amputation
  • Complex Regional Pain Syndrome (CRPS)
    • CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury)
    • CRPS 2 (caused by an injury to the nerve)
  • Reflex Sympathetic Dystrophy (RSD)
    • Reflex Sympathetic Dystrophy Syndrome (RSDS)
    • Complex Regional Pain Syndrome
    • Shoulder-Hand Syndrome
    • Causalgia
    • Sudeck’s Atrophy

Cold Therapy Machines Under Investigation

Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:

  • DonJoy Cold Therapy Machines
  • PolarCare Cold Therapy Machines
  • EBIce Cold Therapy Machines

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

For more information regarding cold therpy lawsuits, please fill out our form on the right side of this page or give our law firm a call at our toll free number (located in the top right corner).

Cold Therapy Attorney

Poorly designed cold therapy machines may cause permanent skin damage (frost bite), nerve damage, and numerious other serious side effects. Seek immidiate medical attention if you are suffering an emergency situation.

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: Unomedical MPR Recall. This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.

Unomedical notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.

Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF- 2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: www.fda.gov/medwatch.

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The webpage is: www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at: www.fda.gov/medwatch.

Zimmer Hip ImplantPatients with constant pain after hip implant surgery may need to speak with their doctor to see if the hip implant has failed. Failed hip implants include any hip implant that has broken, come loose or caused other hip surgery related problems. According to most experts, temporary pain or discomfort after a hip implant surgery is normal and not suggestive of a broken hip implant, femoral head or socket. However, a sudden pain in the implanted hip joint, sometimes preceded by an audible “pop” from the hip just before the onset of pain, is a signal of a hip implant fracture or failure.

Zimmer Durom Cup Hip Implant Failures

Problems with the Durom cup became known in April when a Los Angeles surgeon, Dr. Lawrence Dorr, publicly warned other orthopedists about Durom cup failures he was hearing about from his patients. At that time, Zimmer said it would initiate an investigation but that it saw no reason to take other action, such as halting sales. Zimmer cited European data that indicated that the Durom cup was doing well there; however, the version of the Durom cup used outside the U.S. is a bit different from the one used in the United States. Additionally, while U.S. doctors use the Durom cup in traditional hip replacement surgeries, surgeons in other countries use the device in a relatively new kind of hip surgery known as resurfacing, which involves different surgical techniques.

Hip Implant Fractures and Defective Hip Implants

If a hip implant fractures, surgery to replace it will be necessary. Currently, no tests exist that can predict which patients will experience failure of their hip implants. Patients with recalled hip implants should be closely monitored by their doctors.
Some Zimmer hip implant patients are suffering from what has been described as Zimmer hip pain. Pain in the area of where a hip replacement has been done may indicate a faulty hip implant, loose hip implant, broken hip implant or defective hip implant. Zimmer hip implant patients who are concerned that they may have received a defective artificial hip are urged to contact their orthopedic surgeons or the hospital where their Zimmer hip replacement surgery took place. Concerned patients should request their surgery records from the hospital ’s medical records department to find out if a Zimmer Durom cup hip implant was used in their hip replacement surgery.

NOTE: If you are required to have replacement surgery, tell your Doctors that you want the hip implant to be preserved as evidence and NOT shipped or returned to the manufacturer, as it is critical evidence in a potential product liability lawsuit against Zimmer.

Pain PumpIn 2006, a presentation at an American Academy of Orthopedic Surgeons meeting discussed a study that linked the use of intra-articular pain pumps in shoulder surgeries to a condition called Post-arthroscopic Glenohumeral Chondrolysis (PAGCL). The pain pumps may deliver too much medicine to the shoulder causing a loss of cartilage that can lead to lifelong pain and suffering. There are hundreds of individuals across the country that use high volume pain pumps to cope with the pain that often follows arthroscopic shoulder surgery. These patients have an increased risk of cartilage loss in the shoulder and developing PAGCL.

Shoulder Pain Pumps Under Investigation

Our law firm is investigating cases involving the medical devices manufactured by Stryker Co., DJO Inc., I-Flow Co., BREG Inc. and several others. The most commonly used pain pumps include:

  • Stryker
  • Stryker PainPump 1
  • Stryker PainPump 2
  • PainPump Blockaid
  • I-Flow
  • On-Q Painbuster
  • Donjoy
  • Donjoy Pain Control Device
  • Accufuser Plus Pain Pump

Speak to a Pain Pump Lawyer

If you or a loved one have developed cartilage damage or Post-arthroscopic Glenohumeral Chondrolysis (PAGCL) following arthroscopic surgery, you should contact our law firm immediately.