BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN URETHRAL SUPPORT SYSTEM

    MDR report key: 1212105 · Received October 24, 2008

    Report

    Report Number
    1018233-2008-00074
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK, THEREFORE, NO REVIEW OF DEVICE HISTORY RECORD COULD BE PERFORMED. PER THE INSTRUCTIONS FOR USE IN THE PRECAUTIONS SECTION, IT STATES THAT THE PROPER PLACEMENT OF THE MESH SLING IMPLANT AT THE MID-URETHRA REQUIRES THAT IT LIE FLAT WITH MINIMAL OR NO TENSION UNDER THE URETHRA. IN ORDER TO REMOVE THE SHEATH, IT IS FIRST NECESSARY TO GRASP THE TWO SIDES OF THE MID-POINT TAB AND PEEL THEM AWAY FROM THE CENTER OF THE SHEATH AS INDICATED BY THE ARROWS. THE TAB WILL THEN SLIDE OFF OF THE TWO PROXIMAL ENDS OF THE SHEATH. PLACE A BLUNT INSTRUMENT BETWEEN THE URETHRA AND THE MESH WHILE ADJUSTING AND POSITIONING THE SLING. WHEN THE APPROPRIATE TENSION IS ATTAINED, REMOVE THE SHEATH TO FULLY EXPOSE THE MESH BY PULLING GENTLY ON BOTH SUPRAPUBIC ENDS OF THE SHEATH. KEEP THE BLUNT INSTRUMENT IN PLACE UNDER THE URETHRA WHEN REMOVING THE TWO ENDS OF THE SHEATH TO ENSURE THAT OVER-TIGHTENING OF THE MESH DOES NOT OCCUR. IN THE ADVERSE EVENTS SECTION, IT STATES THAT COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SLING PROCEDURE IN LATE 2007, THE PT EXPERIENCED PAIN IN HER PELVIC REGION AND VAGINAL PAIN ON HER LEFT SIDE. THE PT'S CONDITION WAS DIAGNOSED IN THE DOCTOR'S OFFICE. THE PT WAS GIVEN PRE-OPERATIVE ANTIBIOTICS AND POST-OPERATIVE ANTIBIOTICS. THE DOCTOR SUSPECTED THAT HE HAD PLACED THE MESH TOO TIGHT. THE PT IS SCHEDULED FOR A SURGICAL PROCEDURE IN 2008. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention