BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    MDR report key: 8043833 · Received November 6, 2018

    Report

    Report Number
    2210968-2018-76990
    Event Type
    Injury
    Date Received
    November 6, 2018
    Report Date
    October 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (TENSION-FREE VAGINAL TAPE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: CAN UROL ASSOC J 2013; 7(9-10):E598-600. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.393. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A SEVERE COMPLICATION OF MID-URETHRAL TAPES SOLVED BY LAPAROSCOPIC TAPE REMOVAL AND URETEROCUTANEOSTOMY" AUTHOR(S): TOBIAS SCHÄTZ, MD; STEPHAN HRUBY, MD; DANIELA COLLESELLI, MD; GÜNTER JANETSCHEK, MD; LUKAS LUSUARDI, MD CITATION: CAN UROL ASSOC J 2013; 7(9-10):E598-600. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.393. THIS STUDY PRESENTED AN (B)(6) FEMALE PATIENT WHO UNDERWENT TENSION-FREE VAGINAL TAPE (TVT, GYNECARE) PROCEDURE FOR PERSISTENT STRESS URINARY INCONTINENCE. IN (B)(6) 2010, SHE PRESENTED WITH PERINEAL PAIN, CONTINUOUS INCONTINENCE AND OFFENSIVE SMELLING. URINE CULTURE WAS POSITIVE FOR E. COLI AND CYSTOSCOPY REVEALED SMALL MID-URETHRAL STONE ADHERENT TO THE ERODED TAPE IN THE 6-O¿CLOCK POSITION. VAGINAL EXAMINATION REVEALED PRESENCE OF VAGINAL FISTULA. THE URETHRAL STONE WAS TOTALLY REMOVED WITH COLD CUP BIOPSY FORCEPS AND THE UNDERLYING TAPE WAS DIVIDED AND PARTIALLY REMOVED. THERE WAS AN UNSUCCESSFUL ATTEMPT TO REMOVE THE ERODED TAPE FROM THE LATERAL SIDES OF THE BLADDER NECK AND A SUPRAPUBIC CATHETER WAS INSERTED. CYSTOGRAPHY CONFIRMED THE URETHRO-VAGINAL FISTULA. POST-TREATMENT, THE PATIENT DEVELOPED PAIN AND SWELLING OF THE MONS PUBIS WHICH A 6CM FLUID WAS FOUND ON CT SCAN. SHE WAS STILL INCONTINENT AND IN PAIN. SHE UNDERWENT REMOVAL OF THE TAPE AND PERFORM BILATERAL URETROCUTANEOSTOMY USING MINIMALLY INVASIVE TECHNIQUES. LAPAROSCOPIC SURGERY TO REMOVE THE TAPE WAS SAFE AND EFFICACIOUS IN THIS UNFORTUNATE SCENARIO. LAPAROSCOPY CAN ALSO PROVIDE AN EFFECTIVE SOLUTION FOR INCONTINENCE IN AN ELDERLY, COMORBID PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883414 TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention