BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 3243070 · Received July 18, 2013

    Report

    Report Number
    1018233-2013-02909
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    FTL
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS AWAITING RECEIPT OF THE SAMPLE TO COMPLETE AN INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THERE WERE ANCHOR BREAKS ON 2-AJUST ADJUSTABLE SINGLE INCISION SLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335313 AJUST ADJUSTABLE SINGLE INCISION SLING FTL BARD SHANNON LIMITED NA HUWL0699

    Patients

    Seq Age Sex Outcome Treatment
    1