BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3501365 · Received December 5, 2013

    Report

    Report Number
    2210968-2013-31882
    Event Type
    Injury
    Date Received
    December 5, 2013
    Report Date
    April 15, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)96) 2010 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A TLH, BSO, HEMMROIDECTOMY DUE TO SUI. THE PATIENT EXPERIENCED PAIN, EROSION, URINARY/BOWEL PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    DATE SENT TO THE FDA: (B)(4) 2016. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED NOCTURIA, DYSPAREUNIA, CYSTOCELE, URGENCY, URINARY FREQUENCY, RECTOCELE, VAGINISMUS, AND ENURESIS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT A&P VAGINAL REPAIR, BILATERAL SACROSPINOUS LIGAMENT COLPOSUSPENSION, TOT SLING (ALIGN) IMPLANT AND CYSTOSCOPY ON (B)(6) 2015 DUE TO PELVIC RELAXATION, SUI AND VAGINAL VAULT PROLAPSE. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) VAGINAL PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630242 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3304601

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention