BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3211427 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12414
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 6, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, UTERINE PROLAPSE, URETHRAL HYPERMOBILITY AND INTERSTITIAL CYSTITIS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2008 DUE TO MESH EROSION. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DIFFICULTY IN URINATION, CYSTOCELE, STRESS URINARY INCONTINENCE, AND HYPERMOBILE URETHRA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS 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
    311509 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 860587

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention