Archive for: August, 2008

U.S. FDA

Class A Recall – Polar Care – Medical & Radiation Emitting Device Recalls 

Date Posted August 20, 2008
Recall Number N-0015-2008
Product BREG’s Polar Care 500, Part # 02019; Polar Care 500 Lite, Part # 02020; Polar Care 300, Part #28021.Used for cold therapy after orthopedic surgery.
Code Information All units of the listed models are affected
Recalling Firm/
Manufacturer
Breg Inc, An Orthofix Company
2611 Commerce Way
Vista, California 92081-8439
For Additional Information Contact Kathleen Barber
760-599-5719
Reason for
Recall
This Patient Safety Advisory was initiated to remind users of the risk of cold induced injuries and recommend important safety precautions for BREG Polar Care products.
Action Breg sent a Patient Safety Advisory notice “Dear Dr. letter” dated 09/19/2006 to Distributors & Medical Professionals. The purpose of the letter was to re-educate the orthopedic medical community of the risk of cold induced injuries from cold therapy, including Breg Polar Care products, and to recommend important patient safety precautions, such as not using cold therapy on patients with contraindications and providing a written treatment protocol for each patient. Breg sent a letter, dated May 1, 2007 to all customers, explaining that Breg changed the labeling and instructions with simplified graphics.
Quantity in Commerce 718,000
Distribution Nationwide Distribution.
   

Abstract

Pharmacoepidemiol Drug Saf. 2008 Aug;17(8):801-6.

Källén B, Olausson PO – Tornblad Institute, University of Lund, Lund, Sweden

In order to evaluate the previously published association between maternal use of selective serotonin re-uptake inhibitors (SSRI) and persistent pulmonary hypertension in the neonate (PPHN), we used data from the Swedish Medical Birth Register for the years 1997-2005. Infants were identified from discharge diagnoses, and maternal exposure to drugs from interviews performed in early pregnancy and from prescriptions from the antenatal care service. Putative confounders were studied: an increased risk for PPHN was indicated for high maternal age, for first parity, for maternal BMI, and possibly for maternal smoking. Adjusting for these variables and year of birth, an association between maternal use of SSRI and PPHN in births after 34 completed weeks was identified with a risk ratio of 2.4, 95%CI 1.2-4.3 when based on women who reported the drug use in early pregnancy. When a subgroup of the women were studied who also had prescriptions for SSRI from the antenatal care later in pregnancy, the risk estimate was 3.6, 95%CI 1.2-8.3. The risk estimates were lower than that described previously in the literature, but both estimates could come from the same about 4-5 times increased risk. The mechanism behind the association between SSRI and PPHN is unclear but an increased risk for respiratory problems after maternal use of SSRI is well known, and PPHN could be a rare part of this association.

PMID: 18314924 [PubMed - indexed for MEDLINE]

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