SURGIMEND PRS MESHED 20CM X 10CM X 1MM

Additional Manufacturer Narrative

UPDATED FIELD: H9. THERE IS AN RECALL FOR THE ¿SURGIMEND¿ PRODUCT FAMILY, HOWEVER, AFTER SEVERAL ATTEMPTS, THE CUSTOMER WAS UNABLE TO PROVIDE US WITH A PRODUCT FAILURE AND/OR SPECIFIC ADVERSE EVENT. THEREFORE, WE ARE INCLUDING THE CORRECTION/REMOVAL NUMBER FOR INFORMATIONAL PURPOSES ONLY.

Additional Manufacturer Narrative

SURGIMEND WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED FOR DATA INTEGRITY ISSUES IN ENDOTOXIN TESTING BUT IT IS NOT KNOWN WHETHER THIS IS CONNECTED TO THE EVENT GIVEN THE LACK OF INFORMATION REPORTED.

Description of Event or Problem

A PATIENT REPORTED: "I HAVE MODEL: 606-007-001 IN MY BODY. I JUST FOUND THIS INFO IS AFTER BEING VERY SICK FOR MONTHS." AFTER REQUESTING ADDITIONAL INFORMATION, THE RESPONSE WAS: "I HAVE BEEN VERY SICK. I HAVE EVERY INTENTION TO GET YOU THE INFORMATION. THAT IS THE REASON I REACHED OUT TO YOU." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.