BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1161667 · Received September 15, 2008

    Report

    Report Number
    2210968-2008-00807
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. PT CODE OTHER: BUTTON HOLE OCCURRED. DEVICE CODE OTHER: MESH EXPOSURE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HAMMOCK SLING PROCEDURE APPROXIMATELY EIGHT WEEKS AGO. DURING THE PROCEDURE, THE SURGEON RECOGNIZED A BUTTONHOLE AND REPAIRED IT AT THE TIME OF SURGERY. HOWEVER, WITH RESUMPTION OF INTERCOURSE AT SEVEN WEEKS POST OPERATIVE, HER PARTNER NOTED DISCOMFORT. EXAMINATION REVEALED EXPOSURE OF MESH IN THE VAGINA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK