BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 4170032 · Received October 14, 2014

    Report

    Report Number
    2210968-2014-14540
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT THAT SHE UNDERWENT A SLING PROCEDURE ON (B)(6) 2012. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED MASSIVE PELVIC AND BACK PAIN, INCONTINENCE, UNABLE TO PASS URINE PROPERLY, KIDNEY INFECTIONS, RESTRICTED MOBILITY, AND HER BLADDER WAS FOUND TO BE ADHERED TO THE PUBIC BONE. THE PATIENT WAS PRESCRIBED HIGH DOSES OF MORPHINE. SHE UNDERWENT FIVE PROCEDURES SINCE (B)(6) 2012 IN RELATION TO THE MESH AND TWO WERE UNSUCCESSFUL TO CUT THE SLING AND REMOVE THE MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651327 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3600991

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention