BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3142599 · Received April 5, 2013

    Report

    Report Number
    1018233-2013-01189
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT EXPERIENCED PAIN, INJURY, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2013-01188 AND 1018233-2013-01190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142046 PELVICOL ACELLULAR COLLAGEN BIOMESH FTL TISSUE SCIENCE LABORATORIES NA 02A21

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention