BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRIS SUPRAPUBIC KIT

    MDR report key: 2222064 · Received August 24, 2011

    Report

    Report Number
    2125050-2011-00006
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K053296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THUS, NO EVALUATION HAS BEEN PERFORMED. BECAUSE COLOPLAST'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EROSION, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    PATIENT HAD TOTAL HYSTERECTOMY, A/P REPAIR & MESH BLADDER SLING SURGERY. PATIENT BEGAN HAVING PROBLEMS WITH PAIN, SEVERE BLEEDING AFTER INTERCOURSE & HUSBAND WAS CUT DURING INTERCOURSE. PHYSICIAN CONFIRMED VAGINAL EROSION & REMOVED EXPOSED MESH. THIS HAPPENED AGAIN AND ANOTHER SURGERY TOOK PLACE FOR MESH EROSION. ALTHOUGH DOCTORS SAY THEY CANNOT FIND ANYTHING FURTHER, PATIENT STILL HAS ISSUES WITH PAIN, BLEEDING, BOWEL CONTROL, URINE LEAKAGE, AND BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPRIS SUPRAPUBIC KIT SURGICAL MESH FTL COLOPLAST A/S 5195611400 2093395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention