BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENFORM SOFT TISSUE REPAIR MATRIX

    MDR report key: 6106267 · Received November 16, 2016

    Report

    Report Number
    3005099803-2016-03487
    Event Type
    Injury
    Date Received
    November 16, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAJ
    PMA / PMN Number
    K060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENTS ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED 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. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757867 XENFORM SOFT TISSUE REPAIR MATRIX MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO PAJ BOSTON SCIENTIFIC - MARLBOROUGH UNK166

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention