BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3190597 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11228
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    July 26, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 CONCURRENTLY WITH TOTAL LAPAROSCOPIC HYSTERECTOMY, BSO, LAPAROSCOPIC COLPOPEXY, CYSTOURETHROSCOPY; DUE TO CHRONIC PELVIC PAIN, MENORRHAGIA, URETHRAL HYPERMOBILITY, VAGINAL VAULT PROLAPSE AND SEVERE DYSMENORRHEA. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY; LYSIS OF ADHESIONS; FULGURATION OF SCAR TISSUE; EXCISION OF COLPOPEXY STITCH AND RELEASE OF SCAR TISSUE; FULGURATION OF ENDOMETRIOSIS ON (B)(6) 2009 AND ON (B)(6) 2009 EXCISION OF VAGINAL SCAR TISSUE DUE TO PELVIC PAIN, SCAR TISSUE, ADHESIONS, PAINFUL INTERCOURSE, RETRACTED THICKENED VAGINAL CUFF. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290931 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3082399

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention