BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 4152959 · Received October 8, 2014

    Report

    Report Number
    3005099803-2014-03302
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    EXEMPT
    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, TWO BOSTON SCIENTIFIC DEVICES (MFR REPORT #3005099803-2014-03301 AND MFR REPORT #3005099803-2014-03302) WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INCONTINENCE, INFECTIONS AND PELVIC PAIN. 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
    631832 POLYFORM SYNTHETIC MESH MESH, SURGICAL, POLYMERIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068402401 C000155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other