BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIWRAP

    MDR report key: 1033333 · Received April 23, 2008

    Report

    Report Number
    3004661493-2008-00004
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    February 26, 2008
    Report Date
    April 18, 2008
    Manufacturer
    MAST BIOSURGERY
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE IS NO PRODUCT AVAILABLE FOR EVALUATION THE INVESTIGATION OF THIS COMPLAINT IS LIMITED AND THE COMPANY IS UNABLE TO DRAW A CONCLUSION. THERE IS NO EVIDENCE TO LINK THE SURGICAL INTERVENTION WITH THE PRODUCT DUE TO THE LIMITED INFORMATION PROVIDED BY THE PHYSICIAN. THIS REPORT WAS ORIGINALLY SUBMITTED ON APRIL 18 AS REPORT NUMBER 3004661493-2008-0003 IN ERROR. THE CORRECT NUMBER FOR THIS REPORT IS 3004661493-2008-0004.

    Description of Event or Problem · 1

    IN 2006 THE PT UNDERWENT A REPEAT C-SECTION WITH PERMANENT STERILIZATION. PT HAD SIGNIFICANT ADHESIONS ON ANTERIOR SURFACE ON THE UTERUS AND THE LOWER UTERINE SEGMENT/BLADDER AREA. SURGIWRAP WAS PLACED OVER THIS SURFACE. IN 2008, LAPAROSCOPY WAS PERFORMED AND MULTIPLE GRANULOMA-LIKE NODULES WERE FOUND THROUGHOUT THE PELVIC PERITONEAL SURFACES AND UTERINE WALL SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIWRAP SURGICAL MESH FTL MAST BIOSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization