BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEIVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3142653 · Received March 13, 2013

    Report

    Report Number
    1018233-2013-00822
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO RECEIVED, THE PT UNDERWENT RECTOCELE REPAIR WITH ILIOCOCCYGEUS SUSPENSION OF GRAFT, RIGHT SACROSPINOUS LIGAMENT FIXATION, AND PERINEAL RECONSTRUCTION FOR THE PREOPERATIVE DIAGNOSIS OF APICAL PROLAPSE, HIGH RECTOCELE, AND PERINEAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106623 PEIVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 04B16-1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention RIGHT SACROPINOUS LIGAMENT FIXATION| PERINEAL RECONSTRUCTION