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As of 2018, J&J committed to working with the Indian government to support all Indian ASR patients. In late 2018, an Indian government report, the accuracy of which has been disputed by J&J, proposed that each patient who had a faulty implant should receive a lump sum payment of ₹2 million (US$27,812).
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 ...
Implant failure can occur due to the degradation of the material an implant is made of. With time, mechanical degradation, in the form of wear or fatigue, or electrochemical degradation, in the form of corrosion, can occur. Biotoxicity, particularly in metal implants, can arise due to ion release.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports.
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 ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The original recall notification stated 65 people in nine states were infected with salmonella linked to eggs supplied by Milo's Poultry Farms LLC from May 23 to Aug. 10. No deaths were reported ...
Limited number of episodes of abnormal activity can be stored, [2] with the most recent episode replacing the oldest. [3] Recording can be activated in two ways. First, recording may be activated automatically according to heart rate ranges previously defined and set in the ILR by the physician. If the heart rate drops below, or rises above ...