BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3253974 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15041
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 11, 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

    (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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT ANTERIOR VAGINA REPAIR DUE TO SUI. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION, HYSTEROSCOPY, AND D&C ON (B)(6) 2008 DUE TO POST-MENOPAUSAL BLEEDING. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2007 DUE TO EXPOSED MESH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT HYSTEROSCOPY AND D&C DUE TO POST-MENOPAUSAL BLEEDING ON (B)(6) 2009. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION AND COMBINED ABDOMINOVAGINAL FASCIAL SLING DUE TO RECURRENT STRESS INCONTINENCE AND MESH EROSION ON (B)(6) 2010. 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) 2006 AND MESH WAS IMPLANTED. THE PATIENT IMMEDIATELY SUFFERED SEVERE PAIN, BLEEDING, NUMBNESS AND OTHER COMPLICATIONS. THE PATIENT HAD TROUBLE URINATING, COULD NOT SIT, STAND OR WALK FOR PROLONGED PERIODS OF TIME, HAD PAIN AND INFECTIONS ON AN ONGOING BASIS AND COULD NOT ENGAGE IN SEXUAL RELATIONS WITHOUT PAIN. THE PATIENT HAS UNDERGONE VARIOUS MEDICAL PROCEDURES INCLUDING BUT NOT LIMITED TO SURGICAL PROCEDURES TO REPAIR OR REMOVE THE MESH. ATTEMPTS TO REPAIR OR REMOVE THE ERODED MESH HAVE BEEN UNSUCCESSFUL. THE PATIENT CONTINUED TO EXPERIENCE PAIN, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. THE PATIENT CONTINUES TO LIVE IN PAIN, HAS SUSTAINED PERMANENT AND DEBILITATING INJURIES AND CONTINUES TO EXPERIENCE PROBLEMS WITH INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355527 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 2894573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S