BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1130474 · Received August 20, 2008

    Report

    Report Number
    2210968-2008-00698
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    March 3, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - 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. POST-OPERATIVELY, THE PT EXPERIENCED DISCOMFORT RELATED TO INCOMPLETE EMPTYING OF HER BLADDER AND HAD URINARY RESIDUAL OF SLIGHTLY MORE THAN TWO HUNDRED CUBIC CENTIMETERS. THE SURGEON ADVISED THE PT THAT THE SYMPTOMS WERE DUE TO SWELLING AND ADVISED ADVIL, RELAXATION AND OBSERVATION. THE URINARY RETENTION PERSISTED AND THE PT WAS SCHEDULED ABOUT 4 MONTHS LATER TO HAVE A SLING REVISION TO CUT THE TAPE UNDER THE URETHRA.

    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 66 YR Required Intervention