BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND

    MDR report key: 656229 · Received December 20, 2005

    Report

    Report Number
    3004170064-2005-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2005
    Date of Event
    November 7, 2005
    Report Date
    December 20, 2005
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD INITIAL OPERATION IN 2005, IN WHICH A 10 CM X 15 CM PRODUCT WAS USED TO REPAIR A LARGE (18 CM X 24 CM) VENTRAL HERNIA. MOST OF THE HERNIA WAS CLOSED WITH THE EXCEPTION OF A GAP OF APPROXIMATELY 6 CM. NO PT FASCIA WAS USED AS A REINFORCEMENT. PT RECOVERY WAS UNEVENTFUL. IN MAY 2005, A PT VISIT REVEALED NO BULGING BUT A RIDGE WAS FELT ON THE EDGE. IN JULY 2005, A PT VISIT REVEALED A LARGE (APPROX 12 CM) SEPARATION. IT WAS DIFFICULT TO TELL IF ANY OF THE PRODUCT REMAINED. THERE WAS NO RE-OPERATION AT THIS POINT. IN NOVEMBER 2005, THE SURGEON STATED THAT THE PT HAD A SCHEDULED VISIT ON THE 5TH DAY FOR POTENTIAL RE-OPERATION. A SUBSEQUENT VISIT WITH THE SURGEON IN ABOUT 5 WEEKS LATER REVEALED THAT A RE-OPERATION DID OCCUR IN (9 MONTHS POST IMPLANT). IT WAS OBSERVED THAT THE PRODUCT HAD STRETCHED SIGNIFICANTLY TO ALLOW BULGING. A SMALL PORTION WAS EXPLANTED FOR PATHOLOGY TESTING. THERE WAS NO OBSERVATION OF ADHESIONS TO INTERNAL ORGANS OR OF AN INFLAMMATORY RESPONSE. THE SURGEON SAID THAT, "TECHNICALLY, THERE WAS NO RE-HERNIATION" AS THE PRODUCT STILL CONTAINED THE INTERNAL ORGANS HOWEVER, HE ELECTED TO SUPPLEMENT THE SURGICAL SITE WITH SYNTHETIC MESH BECAUSE HE FELT THE PRODUCT HAD STRETCHED TOO MUCH. THE REMAINDER OF THE PRODUCT WAS LEFT IN PLACE BECAUSE IT HAS VASCULARIZED. AS OF TODAY, THE PT IS STILL DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIMEND SURGICAL MESH FTM TEI BIOSCIENCES INC. 10CM X 15CM SM041109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention