BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATTICE

    MDR report key: 1329101 · Received February 26, 2009

    Report

    Report Number
    1000306051-2009-00007
    Event Type
    Other
    Date Received
    February 26, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 26, 2009
    Manufacturer
    LIFECELL CORP.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT PERFORMED BECAUSE LIFECELL COULD NOT OBTAIN LOT NUMBER. WE CONTINUE TO F/U WITH DR. (B)(6). LIFECELL WILL SUBMIT F/U REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LIFECELL TERRITORY MANAGER THAT THE PATIENT OF DR. (B)(6) DEVELOPED HERNIA RECURRENCE, ABOUT 6 MONTHS POST-OP. DR. (B)(6) STATED THAT THE STRATTICE USED IN ORIGINAL HERNIA REPAIR PROCEDURE (LOT NO IS UNK) HAD TORN ALONG THE MIDDLE OF THE GRAFT WHERE THE HERNIA RECURRED. DR. (B)(6) ALSO COMMENTED, AS FOLLOWS: THERE ARE NO SIGNS OF INFECTION. STRATTICE APPEARED TO HAVE UNEVEN SIGNS OF INTEGRATION. ON (B)(6) 2009, TERRITORY MANAGER MET WITH DR. (B)(6) TO OBTAIN ADDITIONAL INFORMATION NEEDED FOR INVESTIGATION. DR. (B)(6) INDICATED THAT HE WOULD SEND BIOPSY AND INFORMATION TO LIFECELL. LIFECELL ATTEMPTED TO F/U WITH DR. (B)(6) . DR. (B)(6) WAS ON VACATION AND AS OF TO DATE, WE DID NOT OBTAIN BIOPSY AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention