BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 3642700 · Received February 24, 2014

    Report

    Report Number
    2210968-2014-01724
    Event Type
    Injury
    Date Received
    February 24, 2014
    Report Date
    November 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT CYSTOURETHROSCOPY DUE TO GENUINE STRESS INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND PRESSURE IN PELVIC AREA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMPLICATION DURING 05/1620/07 PROCEDURE ¿SPILL FROM BILATERAL URETERS, NO MESH IN URETERS OR BLADDER¿. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, BILATERAL SALPING-OOPHORECTOMY, BILATERAL URETHRAL STENTS, LYSIS OF ADHESIONS AND CYSTOSCOPY ON (B)(6) 2009 DUE TO RESIDUAL OVARY SYNDROME, PELVIC PAIN, DYSPAREUNIA AND PELVIC ADHESIONS. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL STENT REMOVAL ON (B)(6) 2009 DUE TO URETERS BEING TRAUMATIZED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 12/12/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS FURTHER 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
    113302 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention