BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3233621 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13658
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 14, 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 GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES TOTAL VAGINAL HYSTERECTOMY, VAGINAL, PARAVAGINAL REPAIR AND SACROSPINOUS FIXATION DUE TO CYSTOCELE, SUI AND UTERINE PROLAPSE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY AND BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA.

    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 PATIENT UNDERWENT LAPAROSCOPY W/ BSO AND LYSIS OF PELVIC ADHESIONS AND VESTIBULECTOMY WITH VAGINAL ADVANCEMENT ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VAGINAL LACERATION THAT EXTENDED 4CM ON (B)(6) 2007.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTION, URINARY FREQUENCY, AND URINARY INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WERE 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
    333140 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1335647

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention