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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 ...
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.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...
Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.
Philips was recalling some models of the Panorama 1.0T HFO device in the U.S. due to risk of explosion during a "quench procedure" caused by excessive buildup of helium gas. During the procedure ...
In 1990, Congress passed the Safe Medical Devices Act (SMDA), which authorized the FDA to recall devices that pose a risk to patient safety and created the Humanitarian Use Device program to encourage development of devices targeting rare diseases.
The company's devices, BioZorb Marker and BioZorb LP Marker, are implanted in soft tissue, including breast tissue, where the site needs to be marked for future procedures, such as radiation for ...