BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 3599158 · Received January 16, 2014

    Report

    Report Number
    9617613-2014-00076
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    September 17, 2001
    Report Date
    January 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI / PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42932 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 01A03

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other PELVICOL ACELLULAR COLLAGEN MATRIX