BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142539 · Received April 19, 2013

    Report

    Report Number
    1018233-2013-01414
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE, MICRO HEMATURIA, EROSION OF VAGINAL MUCOSA OVER THE SPARC TAPE (2 CM), IRRITATION IN THE VAGINAL AREA PARTICULARLY WITH SEXUAL INTERCOURSE, AND URINARY LEAKAGE WITH COUGHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171112 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 02A19 SB2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention