BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2223504 · Received August 25, 2011

    Report

    Report Number
    2210968-2011-01178
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE EXTREMITY OF THE NEEDLE WAS DAMAGED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THERE WAS DIFFICULTY PUSHING ONE TROCAR/SHEATH THROUGH. ONCE THE SHEATH/TROCAR TIP EMERGED THROUGH THE SKIN, IT WAS NOTICED THAT THE WHITE TIP OF THE SHEATH WAS BENT AT 30 DEGREES AND A CRACK HAD OCCURRED IN THE SHEATH SLIGHTLY EXPOSING THE TROCAR (METAL PORTION). THE SHEATH WAS HOOKED ON THE HANDLE AND SET UP WAS COMPLETED AS RECOMMENDED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON INC NA 3524440

    Patients

    Seq Age Sex Outcome Treatment
    1