BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3478747 · Received November 20, 2013

    Report

    Report Number
    2210968-2013-30473
    Event Type
    Injury
    Date Received
    November 20, 2013
    Report Date
    October 31, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING PROCEDURE THE PATIENT EXPERIENCED LEFT GROIN PAIN, SUBSEQUENTLY ONGOING MARKED NUMBNESS AFFECTING ANTERIOR THIGH, UNABLE TO MOVE LEFT LEG, REQUIRED WALKING STICK. IN (B)(6) 2012, THE PATIENT NOTED TO HAVE CONSTANT PAIN IN THE LEFT GROIN WITH NUMBNESS OF ANTERIOR LEFT LEG, AGGRAVATED BY WALKING OR STANDING, AND DIFFICULTY RAISING LEFT LEG STRAIGHT AND WEAKNESS OF KNEE JOINT EXTENSION. IN (B)(6) 2012, THE PATIENT SYMPTOMS PERSISTED WITH PAIN WORSENING THROUGH THE DAY. THE PATIENT WAS REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE MESH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED OBTURATOR NERVE DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED THAT STATED A BOSTON SCIENTIFIC PRODUCT WAS IMPLANTED INTO THE PATIENT, NOT AN ETHICON PRODUCT. THEREFORE, THIS IS NOT AN ETHICON COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4) - AMBULATION DIFFICULTIES; PAIN OCCURED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL 510K #: K033568.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE ON (B)(6) 2012. THE PATIENT EXPERIENCED NERVE DAMAGE AND NEUROPATHY ON HER LEFT SIDE FOLLOWING THE SURGERY. THE PATIENT HAD ANOTHER SURGERY IN (B)(6) 2013 AND TAPE ON THE LEFT SIDE WAS REMOVED. THE PATIENT REMAINS ON CRUTCHES DESPITE BEING VERY MOBILE BEFORE HER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602714 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention