BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3982914 · Received July 2, 2014

    Report

    Report Number
    1018233-2014-00163
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    PAH
    PMA / PMN Number
    K092607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXATION END WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387054 AJUST ADJUSTABLE SINGLE INCISION SLING PAH BARD SHANNON LIMITED NA HUXH0495

    Patients

    Seq Age Sex Outcome Treatment
    1