FDA Adverse Reaction Cold Therapy System
FDA: Adverse Reaction Model Number 10B
Event Date 11/02/2005
Event Type Injury Patient Outcome Required Intervention;
Disability Event Description
“Ebice 10b cold therapy system was used following 2005 and 2006 podiatric surgical procedures performed for left foot problems and tarsal tunnel syndrome. The patient claims she has suffered cold thermal injury to the ankle, permanent nerve damage, chronic pain and rsd syndrome.”
“Although the unit was not returned for evaluation, the instructions for use was reviewed. Exerts taken from the ifu: read all instructions before using ebice. A licensed health care practitioner must determine the appropriate treatment setting and the length of treatment for each patient. Individual sensitivity to a cryotherapy application varies. It is important to periodically check the color and sensitivity of the skin at the treatment site. The patient should be instructed that if the skin appears discolored or feels numb, immediately discontinue the cold therapy treatment and notify your health care practitioner. Cooling for one hour at a water temperature of 30 – 48 deg f may induce redness and edema that last for 24 hours after exposure. Some individuals are allergic to cold, reacting with hives, joint pain and swelling. When cryotherapy is selected as a treatment modality, close monitoring of the patient’s response to the cryotherapy treatment is critical. Water cycling adjustments or discontinuation of the treatment may be required if a patient demonstrates a localized hypothermia reaction. With a sudden sharp and persistent drop in temperature, vasoconstriction and increased viscosity of the blood in a local area may cause ischemic injury and degenerative changes in peripheral nerves. Localized reaction to cold may include childbain, frostbite or immersion syndrome. Prolonged tissues hypoxia and infarction necrosis of the affected tissue may develop. Vascular injury and edema become more evident as the temperature returns to normal.”
Poorly designed cold therapy machines can cause permanent nerve damage, frostbite, and numerious other serious side effect injuries. Seek immediate medical attention if you are suffering an emergency situation.
Cold therapy lawsuits are currently being filed by attorneys 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.
If you or someone you know has been injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to a Cold Therapy Machine Attorney at the Willis Law Firm in Houston for legal advice about a potential cold therapy – cryotherapy lawsuit. Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.