BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1081694 · Received July 24, 2008

    Report

    Report Number
    2210968-2008-00593
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MESH EXPOSURE OCCURRED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. POST-OPERATIVELY, THE PT REPORTED THAT HER HUSBAND COULD FEEL MESH WITH INTERCOURSE. AN EXAMINATION FOUND A TWO TO THREE MILLIMETER MESH EXPOSURE IN THE LEFT SULCUS. THE SURGEON HOPES THAT THE PT WILL CONSENT TO VAGINAL ESTROGEN CREAM USE FOR ONE MONTH FIRST BUT IF THE EXPOSURE DOES NOT HEAL, THEN THE SURGEON WILL PROCEED SURGICALLY.

    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 Required Intervention