Davol Bard Composix Kugel Hernia Mesh Patch
08/14/2007
Episode Description
FDA records show that as far back as 2002, Davol Bard began to receive complaints about broken rings in the extra large versions of the patch. Davol initially blamed the broken devices on doctors improperly folding the patches for placement during hernia repair. It was not until December 2005 that Davol ran tests and realized that the broken rings were not due to doctor error, but rather failure at the ring weld. In 2006, the FDA found that Davol was tracking complaints about the hernia patch improperly and that adverse reports were understated.
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