BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1233403 · Received November 12, 2008

    Report

    Report Number
    2210968-2008-01099
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    June 10, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    k974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L 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 IN 2008. WITHIN FOUR WEEKS, THE PT EXPERIENCED A MESH EROSION IN THE VAGINA. THE EVENT IS ONGOING.

    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 UNKNOWN Required Intervention