BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3254092 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15053
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/17/2013. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2010 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE ON (B)(6) 2007 AND MESH WAS IMPLANTED. THE PATIENT IMMEDIATELY SUFFERED SEVERE PAIN AND A BLOCKAGE IN THE URETHRA RENDERING HER UNABLE TO URINATE INDEPENDENTLY. ALSO, SHE CONTINUED TO SUFFER FROM SEVERE INCONTINENCE, PELVIC PAIN AND INFECTIONS ON AN ONGOING BASIS. THE PATIENT HAS UNDERGONE VARIOUS MEDICAL PROCEDURES INCLUDING BUT NOT LIMITED TO VARIOUS SURGICAL PROCEDURES IN AN ATTEMPT TO REMOVE THE ERODED MESH. ATTEMPTS AT MESH REMOVAL HAVE BEEN UNSUCCESSFUL. SHE CONTINUES TO LIVE IN PAIN AND HAS SUSTAINED PERMANENT AND DEBILITATING INJURIES . NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355823 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2987230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S