BEUDAMED
    FDA Adverse Event Death Summary report: N

    XENFORM SOFT TISSUE REPAIR MATRIX

    MDR report key: 5094345 · Received September 22, 2015

    Report

    Report Number
    3005099803-2015-02667
    Event Type
    Death
    Date Received
    September 22, 2015
    Report Date
    September 1, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAJ
    PMA / PMN Number
    K060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT'S ATTORNEY, A BOSTON SCIENTIFIC DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN, DISABILITY AND DEATH. 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
    626981 XENFORM SOFT TISSUE REPAIR MATRIX MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO PAJ BOSTON SCIENTIFIC - MARLBOROUGH M0068302450 0000905003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death