BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AJUST HELICAL SINGLE-INCISION SLING

    MDR report key: 3061593 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01296
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    FTL
    PMA / PMN Number
    K123179
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 ANCHOR BROKE DURING THE PROCEDURE. ANOTHER KIT WAS OPENED AND THE ANCHOR BROKE ON IT ALSO. ANOTHER SLING WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154499 AJUST HELICAL SINGLE-INCISION SLING FTL BARD SHANNON LIMITED NA HUWI0148

    Patients

    Seq Age Sex Outcome Treatment
    1