BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3122382 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05727
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN THE (B)(6) 2008. FOLLOWING THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING PAIN ON THE LEFT SIDE WHICH WAS TREATED WITH HORMONES. THE PATIENT CONTINUES TO HAVE LEFT SIDED PAIN AND PAIN DURING INTERCOURSE. THE PATIENT IS ALSO EXPERIENCING MORE URINE LEAKAGE. THE PATIENT WAS SEEN BY THE GYNECOLOGIST AND HAS AN APPOINTMENT WITH THE SURGEON ON (B)(6) 2013 TO DISCUSS OPTIONS AND POSSIBLE REMOVAL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224503 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention