BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX UGYTEX MESH

    MDR report key: 6206278 · Received December 27, 2016

    Report

    Report Number
    9617613-2016-00147
    Event Type
    Injury
    Date Received
    December 27, 2016
    Report Date
    November 30, 2016
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENT DATE WAS NOT PROVIDED. IMPLANT AND EXPLANT DATE WERE NOT PROVIDED. LOT NUMBER NOT PROVIDED. UDI NOT PROVIDED. RE-PROCESSING INFORMATION NOT PROVIDED. SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT WAS IMPLANTED WITH A MESH DEVICE. AFTER THE PELVIC MESH WAS IMPLANTED THE PATIENT BEGAN TO EXPERIENCE SEVERE COMPLICATIONS RELATED TO THE IMPLANT, INCLUDING BUT NOT LIMITED TO EXTREME PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA AND UPON INFORMATION AND BELIEF UNDERWENT MULTIPLE CORRECTIVE SURGERIES TO REMOVE OR REVISE PART OF THE PELVIC MESH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857123 UNKNOWN PARIETEX UGYTEX MESH MESH, SURGICAL, POLYMERIC FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABOR UNKPARUGYTEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R