BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2021615 · Received March 10, 2011

    Report

    Report Number
    2210968-2011-00276
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 12, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). URINARY RETENTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN OBTURATOR SLING PROCEDURE AND AN ANTERIOR COLPORRHAPHY FOR A VERY LARGE CYSTOCELE (ST 3-4). THE PT HAD AN INDWELLING CATHETER FOR A WHILE AND AFTER REMOVAL STILL ONLY VOIDED SMALL AMOUNTS WITH LARGE RESIDUALS. THE PT DECLINED TO HAVE AN INDWELLING CATHETER REINSERTED. THE PT CAME BACK IN ACUTE RETENTION WITH 1700CC IN THE BLADDER. A CATHETER WAS REINSERTED AND THE PT WAS PUT ON A BLADDER RELAXANT. THE SURGEON PERFORMED A CYSTOSCOPY AND THE TAPE DOES NOT SEEM TO BE TIGHT AND NORMAL BLADDER INSPECTION WAS NOTED. IT IS PLANNED TO HAVE THE PT START SELF-CATHETERIZING AND IF THE PT DOES NOT SHOW ANY SIGNS OF IMPROVEMENT OVER TIME IT MAY BE NECESSARY TO RELEASE THE TAPE.

    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