BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIX

    MDR report key: 2826975 · Received November 5, 2012

    Report

    Report Number
    MW5027547
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE SUTURING IN SLING, BOTH END WITH BARBS POPPED OFF. SECOND SLING WAS THEN SUTURED IN PLACE. THE SECOND SLING HAD THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLIX SLING FTL BOSTON SCIENTIFIC 34572 M10000908

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other