BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2032811 · Received March 29, 2011

    Report

    Report Number
    2210968-2011-00367
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. ADDITIONAL INFORMATION: CONCLUSION (B)(4) - THE VISUAL EXAMINATION OF THE RETURNED DEVICE COMPONENTS WAS PERFORMED. THE PRODUCT WAS USED. THE MESH WAS DETACHED FROM THE PROLENE LINE AND FROM THE NEEDLE. NO FUNCTIONAL EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/29/2011. (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, THE SURGEON BUTTON-HOLED THE SULCUS OF THE VAGINA ON THE RIGHT LATERAL SIDE. THE SIZE OF THE BUTTON HOLE WAS APPROXIMATELY THE DIAMETER OF A DEVICE INSERTER. THE BUTTON HOLE WAS REPAIRED WITH SUTURE. THE DEVICE WAS REMOVED BECAUSE THE MESH NO LONGER FIT THE IMPLANT SITE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS POST-PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention