BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELEX MESH

    MDR report key: 4172441 · Received October 10, 2014

    Report

    Report Number
    2242352-2014-01085
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 14, 1997
    Report Date
    September 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    FTL
    PMA / PMN Number
    K945377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL COMPLAINT NO: (B)(4).

    Description of Event or Problem · 1

    PT STATES AS A RESULT OF THE IMPLANT, HAS SUFFERED EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NEUROPATHIC AND OTHER ACUTE AND CHRONIC NERVE DAMAGE AND PAIN, PUDENDAL NERVE DAMAGE, PELVIC FLOOR DAMAGE, CHRONIC PAIN, OPERATIONS TO LOCATE AND REMOVE MESH, OPERATIONS TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE AND NERVE DAMAGE, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE AND THE VAGINA AND OPERATIONS TO REMOVE PORTIONS OF THE FEMALE GENITALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643221 TRELEX MESH NONE FTL MAQUET CARDIOVASCULAR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other