BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX

    MDR report key: 3152121 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02180
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 26, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    COMPLAINT # (B)(6). IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-02179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230528 PELVICOL ACELLULAR COLLAGEN MATRIX FTL TISSUE SCIENCE LABORATORIES NA 04B08-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMS MONARC HAMMOCK