BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1233863 · Received November 13, 2008

    Report

    Report Number
    2210968-2008-01113
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    September 23, 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 Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    URINARY RETENTION OCCURRED - CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2008. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY, AND VOIDING FUNCTION AT THAT TIME WAS NORMAL. ON FOUR DAYS LATER, THE PATIENT WAS EXPERIENCING URINARY RETENTION. THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF VOIDING DYSFUNCTION AND WAS FOUND TO HAVE HIGH RESIDUALS. THE PATIENT HAD A PULL DOWN OF THE TAP PROCEDURE UNDER GENERAL ANESTHESIA ON THE NEXT DAY WITH RESOLUTION OF VOIDING PROBLEMS. THE EVENT WAS RESOLVED ON THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3163247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention