BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1163139 · Received September 16, 2008

    Report

    Report Number
    2210968-2008-00824
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/16/2008. CONCLUSION: 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 AN OBTURATOR SLING PROCEDURE IN 2008. A VAGINAL HYSTERECTOMY AND A PELVIC FLOOR REPAIR BY SACROSPINOUS LIGAMENT FIXATION WERE ALSO COMPLETED AT THAT TIME. DURING THE PROCEDURE, THERE WAS A LEFT-SIDED BLADDER PERFORATION BY THE WINGED GUIDE. SURGICAL INTERVENTION WAS TAKEN AND THE OUTCOME WAS RESOLVED THE SAME DAY. THE SURGEON CHECKED BOTH SIDES WITH A CYSTOSCOPE AFTER THE PERFORATION INCIDENT AND THEN DOUBLE-CHECKED WITH A CYSTOSCOPE AFTER THE SLING PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3135654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention