BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUST HELICAL SINGLE INCISION SLING

    MDR report key: 3042229 · Received April 4, 2013

    Report

    Report Number
    1018233-2013-01171
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    FTL
    PMA / PMN Number
    K123179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 DOCTOR ATTEMPTED TO PLACE AN AJUST HELICAL PRODUCT UNSUCCESSFULLY. THIS WAS THE FIRST TIME USE OF THIS DEVICE BY THE DOCTOR. THE PT WAS DESCRIBED AS OVERWEIGHT. THE DOCTOR ENCOUNTERED DIFFICULTY IN ANCHORING THE LEFT SIDE AND AFTER MULTIPLE ATTEMPTS ANCHOR BREAKAGE OCCURRED WITH 2 ANCHORS. THE MESH WAS CUT AWAY AND NOT IMPLANTED. FOLLOWING, THE DOCTOR DECIDED TO USE A DIFFERENT MESH PRODUCT WHICH THE DOCTOR WAS FAMILIAR WITH USING. IT WAS REPORTED THAT DURING THIS TIME OF PLACING THIS MESH PRODUCT THE DOCTOR PERFORMED A CYSTOSCOPY TO DETERMINE IF THE VAGINA WAS CUT. THE CYSTOSCOPY INDICATED THE URETHRA WAS CUT AND NOT THE VAGINA. A UROLOGIST WAS CONSULTED. THE ALTERNATE MESH PRODUCT WAS REMOVED, THE PT'S URETHRA WAS SUTURED AND THE PT WAS SENT HOME WITH AN INDWELLING CATHETER. THE SURGICAL PROCEDURE WAS NOT COMPLETED. ASSOCIATED MDRS 1018233-2013-01117, 01173.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137911 AUST HELICAL SINGLE INCISION SLING FTL BARD SHANNON LIMITED NA HUWJ1211

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention AJUST SINGLE INCISION SLING| ALIGN TO URETHRAL SUPPORT SYSTEM