BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL (BARD) 8CM X 12CM

    MDR report key: 6139842 · Received December 1, 2016

    Report

    Report Number
    9617613-2016-00140
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    May 23, 2005
    Report Date
    September 21, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). (B)(4).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). (B)(4). SECTION D4: LOT NUMBER NOT PROVIDED. SECTION D4: UDI NOT PROVIDED. SECTION D8: RE-PROCESSING INFORMATION NOT PROVIDED. SECTION H4: SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE DIAGNOSIS: STRESS URINARY INCONTINENCE, CYSTOCELE, RECTOCELE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788891 PELVICOL (BARD) 8CM X 12CM MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR 482212 04B20-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other MESH (B)(6) 2005.PRECISION TWIST.| MESH PRECISION TWIST.