BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3203137 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11958
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    August 2, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 07/26/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED ALONG WITH CONCURRENT COLPORRHAPHY AND POSTERIOR RECTOCELE DUE TO RECTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, RECURRENCE, NOCTURIA AND DYSPAREUNIA. IT WAS ALSO REPORTED THAT ON (B)(6) 2008, THE ALIGN URETHRAL SUPPORT SYSTEM WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT POSTERIOR COLPORRHAPHY AND PERINEORRHAPHY. IT WAS REPORTED THAT PATIENT UNDERWENT VAGINAL HYSTERECTOMY, UTEROSACRAL LIGAMENT SUSPENSION, POSTERIOR COLPOPERINEORRHAPHY, ALIGN SLING IMPLANT AND CYSTOSCOPY ON (B)(6) 2008 DUE TO POP AND SUI. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED ALONG WITH CONCURRENT COLPORRHAPHY AND POSTERIOR RECTOCELE DUE TO RECTOCELE AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, RECURRENCE, NOCTURIA AND DYSPAREUNIA. IT WAS ALSO REPORTED THAT ON (B)(6) 2008, THE ALIGN URETHRAL SUPPORT SYSTEM WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND THE ALIGN URETHRAL SUPPORT SYSTEM AND MESH WERE IMPLANTED. THE PATIENT 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
    302822 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention