BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3221057 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12838
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    March 18, 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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TAH/BSO AND TENSION-FREE VAGINAL TAPING THROUGH THE OBTURATOR FORAMEN DUE TO UTERINE PROCIDENTIA, GENUINE STRESS URINARY INCONTINENCE, URINARY RETENTION, AND UTERINE PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, ORGAN PERFORATION, DYSPAREUNIA, VAGINAL SCARRING, AND DAMAGED HUSBAND¿S PENIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND CYSTOSCOPY ON (B)(6) 2013 FOR MESH EROSION AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION (CUTTING OF THE WIRE EXPOSED IN UPPER VAGINAL CANAL) ON (B)(6) 2013 DUE TO PAIN AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 DUE TO ¿PAIN I WAS EXPERIENCING AND BECAUSE I COULD NOT HAVE SEXUAL INTERCOURSE.¿ NO ADDITIONAL INFORMATION WAS PROVIDED. 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 THAT PATIENT UNDERWENT REMOVAL OF MESH ON (B)(6) 2013 DUE TO VAGINAL MESH DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TAH AND BSO. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2013 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
    320432 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3650287

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention