BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLIGEN MARTRIX

    MDR report key: 2901256 · Received December 13, 2012

    Report

    Report Number
    9617613-2012-00274
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    May 19, 2005
    Report Date
    November 16, 2012
    Manufacturer
    COVIDIENT, FORMERLY TISSUE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: (B)(6), DATE OF REPORT: (B)(4) 2012, DEVICE MFR: TISSUE SCIENCE LABORATORIES, (B)(4). (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM IMPORTER REPORT: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLIGEN MARTRIX PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE NA 04B16-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other