BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENFORM SOFT TISSUE REPAIR MATRIX

    MDR report key: 6156382 · Received December 8, 2016

    Report

    Report Number
    3005099803-2016-03713
    Event Type
    Injury
    Date Received
    December 8, 2016
    Report Date
    November 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PAJ
    PMA / PMN Number
    K060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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 AN UNKNOWN INJURY. 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
    806056 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 Other