BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO MESH 9 X 12

    MDR report key: 3022790 · Received March 26, 2013

    Report

    Report Number
    MW5029476
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    July 7, 2005
    Report Date
    March 26, 2013
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER HAD THE SURIPRO MESH PLACED FOR AN INGUINAL HERNIA REPAIR. IN THE HOSP SHE DEVELOPED (B)(6) AND WAS DISCHARGED WITH A PICC LINE. ALSO HAD TO HAVE HER WOUND REOPENED AND USED A WOUND VAC FOR 11 MONTHS. THERE IS NO RELIEF FOR THE PAIN. HAS MASSIVE AMOUNTS OF SCAR TISSUE FROM THE MESH. PROCEDURE DONE AT (B)(6). WOULD ALSO LIKE TO ADD THAT THE MESH PROTRUDES WITH PROLONGED STANDING AND SITTING. CURRENTLY ON A LOT OF MEDICATION FOR PAIN AND ANXIETY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM REPORTER (B)(6) 2013: WANTS TO KNOW IF DEVICE HAS BEEN RECALLED, SPECIFICALLY THE LOT NUMBER OF HER DEVICE. SHE WAS NOT NOTIFIED OF THE RECALL FOR 3 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124363 SURGIPRO MESH 9 X 12 SURGIPRO MESH 9 X 12 FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR