BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 2768711 · Received September 17, 2012

    Report

    Report Number
    9617613-2012-00185
    Event Type
    Injury
    Date Received
    September 17, 2012
    Report Date
    August 17, 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). DATE OF INITIAL REPORT SENT: 09/14/2012. NOTE: THIS REPORT CORRESPONDS WITH REPORT #(B)(4) FOR A "PELVICOL". DATE OF REPORT: 08/14/2012; DEVICE MFR: TISSUE SCIENCE LABORATORIES, (B)(4); (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. ADD'L DATA FROM IMPORTER REPORT: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L 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 04B07-9

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| O