BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1964063 · Received January 11, 2011

    Report

    Report Number
    2210968-2011-00039
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). URINARY TRACT INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 A SLING PROCEDURE ON (B)(6) 2010. AT SIX WEEKS POST-OPERATIVELY, THE PATIENT REPORTED TUGGING FEELINGS INTERNALLY, BUT THIS WAS ATTRIBUTED TO HEALING. BY FOUR AND A HALF MONTHS POST-OPERATIVELY, THE PATIENT BEGAN HAVING REPEATED URINARY TRACT INFECTIONS AND CONSTANT INTERNAL SORENESS. THE PATIENT HAS EXPERIENCED SEVERE INFLAMMATION, INFECTION AND SWELLING. THE PATIENT WAS TREATED WITH A FOUR-WEEK DOSE OF CIPROFLOXACIN AND IS NOW ON A DAILY ANTIBIOTIC AND ANTI-INFLAMMATORY MAINTENANCE. THE PATIENT IS WAITING FOR AN MRI AND A SECOND CYSTOSCOPY UNDER ANESTHETIC. THE PATIENT WENT FOR A SECOND CONSULTANT OPINION AND WAS TOLD THAT THE SLING MAY HAVE TO BE REMOVED EARLY IN THE NEW YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3374654

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention