BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2103126 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00677
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST OPERATIVE LOWER EXTREMITY PAIN. 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 AN OBTURATOR SLING PROCEDURE APPROXIMATELY THREE MONTHS AGO. UPON WAKING FROM THE PROCEDURE, THE PATIENT EXPERIENCED PAIN IN HER MEDIAL AND LATERAL LEFT THIGH. WHEN THE PATIENT WAS EXAMINED FOR POINT TENDERNESS IN THE VAGINA, IT DID ELICIT SOME PAIN BOTH IN THE VAGINA AND THIGH. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED PERSISTENT PAIN. THE PATIENT HAS REQUIRED NARCOTIC ANALGESICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention