BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTRYX MESH SLING SYSTEM

    MDR report key: 1172849 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04749
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK; CONSEQUENTLY THE DEVICE MFR AND EXPIRATION DATES ARE UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING THE MIDURETERAL SLING PROCEDURE USING AN OBTRYX MESH SLING SYSTEM, THE METAL FASTENER OVER THE TROCAR BROKE OFF. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX MESH SLING SYSTEM FTL BOSTON SCIENTIFIC CORPORATION M0068504000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK