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News release
 

FDA Issues Advisory on Unretrieved Device Fragments

On January 15, the Food and Drug Administration (FDA) issued a public health notification to health care practitioners on how to avoid fragments that unintentionally separate from a medical device and remain in the patient after a procedure. The agency recommended health care practitioners use medical devices in accordance with their labeled indications and the manufacturer's instruction; inspect devices for damage before use and on removal from the patient; keep damaged devices to help with the manufacturer's analysis; and advise patients about the safety of unretrieved fragments. FDA's Center for Devices and Radiological Health receives nearly 1,000 adverse event reports each year related to unretrieved device fragments.

More information is available at http://www.fda.gov/cdrh/safety/011508-udf.html.


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