BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1790038 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00865
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URINARY RETENTION. 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 A SLING PROCEDURE ON (B)(6) 2010. THE URINARY CATHETER WAS REMOVED ON (B)(6) 2010 AND THE PT WAS UNABLE TO PASS URINE. THE PT WAS DISCHARGED THE NEXT DAY AND TOLD TO SELF CATHETERIZE. ON (B)(6) 2010, CYSTOSCOPY AND URETHRAL DILATION WERE PERFORMED BECAUSE THE NECK OF THE BLADDER WAS TOO TIGHT. THE PT HAD URGE INCONTINENCE AND THEN WAS UNABLE TO URINATE AGAIN. TAMSULOSIN AND CIPROFLOXACIN WERE PRESCRIBED. ON (B)(6) 2010, A PROCEDURE TO REMOVE THE TAPE WAS PERFORMED. SOME TAPE WAS EMBEDDED AROUND THE SURROUNDING TISSUE AND THE URETHRA WAS ACCIDENTALLY CUT AND HAD TO BE STITCHED. AN IN-DWELLING CATHETER WAS PLACED AND REMOVED ON (B)(6) 2010. THE PT DEVELOPED PAIN AND MORPHINE WAS STARTED WITH GOOD EFFECT. THE PT IS NOW ABLE TO PASS URINE BUT IS STILL SELF CATHETERIZING RESIDUAL URINE.

    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 32 YR Required Intervention