BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1020686 · Received March 28, 2008

    Report

    Report Number
    2210968-2008-00201
    Event Type
    Injury
    Date Received
    March 28, 2008
    Report Date
    February 27, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/27/2008. 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. AFTER THE PROCEDURE, THERE WAS IMPROVEMENT IN URINARY LEAKAGE; HOWEVER, THE PT WAS STILL EXPERIENCING A SMALL AMOUNT OF URINE LEAKAGE WITH STRESS. ON AN UNK DATE THE SURGEON NOTED A "BABY PEA-SIZED HOLE" THAT "WASN'T ABSORBED TOTALLY". TWO MONTHS LATER, THE PT WAS SEEN BY THE SURGEON AND WAS TOLD THAT THE SURGERY HAD FAILED AND THAT THE "RIGHT SIDE OF THE MESH HAD GOTTEN WIDER". THE SURGEON IS PLANNING TO PERFORM AN UNK TYPE OF SURGERY.

    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