BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2163113 · Received July 15, 2011

    Report

    Report Number
    2210968-2011-00897
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INCONCLUSIVE - THE TWO NEEDLES WERE ON THE PASSERS AND THE MESH WAS COMPLETE WITH THE PLASTIC AND CONNECTED TO THE NEEDLES. THE NEEDLE WAS BENT AND IN A POSITION WHERE THE PASSER WAS NOT FULLY INSERTED INTO THE NEEDLE. THERE IS EVIDENCE THAT THE PRODUCT WAS USED BECAUSE OF THE OBVIOUS SIGNS OF BLOOD ON THE PRODUCT. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE ON (B)(6) 2011. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PLASTIC TUBE WAS BROKEN BUT STILL ATTACHED, RIGHT OUT OF THE PACKAGE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE 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 NA 3506774

    Patients

    Seq Age Sex Outcome Treatment
    1