BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 2901255 · Received December 13, 2012

    Report

    Report Number
    9617613-2012-00275
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 15, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE... NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other