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An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints. [ 5 ] In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, seven reported deaths, and many additional side effects, all linked to Essure, its specific chemical ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.
DePuy Synthes (/ d ə ˈ p j uː /) is a franchise of orthopaedic and neurosurgery companies.Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson MedTech business segment.
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There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. B. Braun Medical did not immediately respond to a Reuters request for comment.
When the whole CI500 family was recalled in 2011 due to soft failures of some CI512 implants, the CI500 family consisted of the CI512 and CI513 cochlear implants, the CI522, CI532 which had a perimodular electrode array, CI551 which had a double array, and the Nucleus ABI 541, which was an auditory brainstem implant version of the product.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.