BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3892138 · Received June 24, 2014

    Report

    Report Number
    2210968-2014-08131
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. 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 ON AN UNKNOWN DATE. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT WAS UNABLE TO MOVE HER LEFT LEG. THE PATIENT HAD A COMPLETE INABILITY TO USE HER LEG FROM THIGH TO THE FOOT, POSSIBLE NERVE DAMAGE. THE PATIENT EXPERIENCED A COMPLETE PELVIC AND BLADDER LACK OF SENSATION AND FEELING FOR EIGHT MONTHS THEN EXTREME PELVIC AND VAGINAL PAIN. THE PATIENT HAD AN INABILITY TO ROTATE HER LEG SIDEWAYS. THE PATIENT CAN WALK WITH CRUTCHES, BUT CANNOT WALK MORE THAN 200 METERS. THE PATIENT TOOK 6 MONTHS TO LEARN TO WALK AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368723 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3705418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention