BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1150505 · Received September 4, 2008

    Report

    Report Number
    2210968-2008-00786
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    February 29, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/04/2008. (COUGHING OCCURRED), (TEARING SENSATION OCCURRED), (MESH BUNCHING OCCURRED) CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 IN 2007. THERE WERE NO COMPLICATIONS UNTIL AFTER AN EPISODE OF BRONCHITIS/SEVERE COUGHING IN 2008, WHEN THE PATIENT FELT A TEARING SENSATION AND PAIN WHICH FELT LIKE BEING STUCK WITH BROKEN GLASS. THE PATIENT RETURNED TO HER SURGEON FOR A REVISION THREE MONTHS LATER, WHERE THE SURGEON STATED THERE WAS A WRINKLE IN THE MESH WHICH HE SMOOTHED OUT. THE SURGEON ALSO TRIMMED A CORNER OF THE MESH THINKING THAT THESE ACTIONS WOULD RELIEVE THE PATIENT'S SYMPTOMS. THE PATIENT'S PAIN HAS CONTINUED TO THE PRESENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 2978403

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention