At least three people have died from complications related to a surgically implacted tissue reinforcement products sold by medical device maker Covidien under the brand name Duet TRS. The Covidien Duet TRS, launched in 2009, is system the company sold to … Continue reading
Covidien Duet TRS linked to deaths and serious injuries
Posted in Defective Medical Devices
Tagged covidien, tissue-reinforcement
Avaira contact lenses by CooperVision recalled due to eye injuries
Contact lens maker CooperVision has expanded a recall of millions of contact lenses, due to eye injuries, which now includes Avaira Sphere lenses and Avaira Toric lenses. The FDA announced the second wave of Avaira recalls, covering the Sphere lenses, on … Continue reading
Posted in FDA warnings, Recalled Products, vision loss
Avaira Sphere contact lens recall – lot numbers
The following FDA announcement discloses specific lot numbers included in the CooperVision Avaira Sphere contact lens recall: Avaira Recall – Lot Numbers FDA Enforcement Report for December 21, 2011 http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm284545.htm -=-=-=-=-=-=-=-=-=- PRODUCT AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear … Continue reading
Posted in FDA warnings, Recalled Products, vision loss
CooperVision Recalls Some 6.6 Million Contact Lenses
On Nov. 15, 2011, CooperVision announced that it was expanding its contact lenses recall to include certain lots of Avaira Sphere contact lenses. The initial recall, issued in August 2011, involved the Avaira brand product line of contact lenses. According … Continue reading
Posted in Defective Medical Devices
Tagged contact lens recall
FDA warns Animas for selling pumps after learning of defects
The following is the text of a warning letter the FDA sent to Animas, a division of Johnson & Johnson, on Dec. 27, 2011, as released to the public Jan. 10, 2012. Animas Corporation 12/27/11 Department of Health … Continue reading
Posted in insulin pumps
Johnson & Johnson kept selling Animas insulin pumps after learning of malfunctions
Animas, a Johnson & Johnson company, knew of malfunctions in its insulin pumps, but continued selling those models of insulin pumps anyway, according to an FDA warning letter sent to the company Dec. 27 and released to the public Jan. 10. … Continue reading
Posted in insulin pumps
Tagged animas, fda-letter, fda-warnings, jnj
FDA scientists say blood clot risk should be added to Yaz and Yasmin labels
Consumers of Yaz and Yasmin birth control pills should be warned of the serious risk of dangerous blood clots linked to the drugs, said FDA scientists in a written report. In documents released Tuesday, in advance of a Thursday panel hearing, the Food and … Continue reading
Posted in Yasmin-Yaz
Tagged bayer, fda
Pfizer loses $72 million verdict in hormone therapy breast cancer lawsuit
A Philadelphia jury awarded $72 million to three women who contracted breast cancer after taking Pfizer’s hormone replacement therapy drugs, sold under the name Prempro. Jurors in a Pennsylvania state court announced their decision after deliberating for two days. The … Continue reading
Posted in Hormone Replacement Therapy
Tagged e+p, hormone-therapy, hrt, jury-verdicts, premarin, prempro, provera, upjohn, wyeth
Halliburton destroyed key oil spill evidence, alleges BP
In the ongoing legal battle between Gulf oil spill companies, BP is accusing Halliburton of purposefully destroying crucial evidence that would reveal problems with the cement slurry Halliburton put into the Deepwater Horizon well. BP asked U.S. District Judge Carl … Continue reading
Posted in BP Oil Spill Disaster
Tagged bp-oil-rig, halliburton
Former FDA Commissioner says Bayer hid blood clot dangers of Yasmin and Yaz birth control pills
A former head of the FDA says Bayer hid reports of dangerous blood clots from the FDA, according to court documents released Monday by a U.S. federal court in Illinois. Bayer attorneys have been trying to prevent former FDA Commissioner David … Continue reading
Posted in Yasmin-Yaz
Tagged blood clots, fda, VTE