BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3243219 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14225
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    September 19, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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

    (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 CONCURRENTLY UNDERWENT TOTAL VAGINAL HYSTERECTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES; TVH, ANTERIOR VAGINAL REPAIR AND MESH FOR CYSTOCELE, UTERINE PROLAPSE, SUI, AND MENORRHAGIA ON (B)(6) 2009 AND MESH WAS IMPLANTED AND A SACROSPINOUS LIGAMENT VAGINAL VAULT SUSPENSION, POSTERIOR COLPORRHAPHY, PERINEORRHAPHY, ANTERIOR COLPORRHAPHY WITH MESH FOR STAGE II POP, AND PERINEAL BODY DEFECT, ON (B)(6) 2011 AND MESH WAS IMPLANTED AND INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343126 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3195458

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention