BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3150716 · Received June 6, 2013

    Report

    Report Number
    2210968-2013-10022
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 23, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THE MESH WAS IMPLANTED DUE TO URODYNAMIC STRESS INCONTINENCE WITH CONCURRENT CYSTOSCOPY. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT REVISION OF VAGINAL MESH EROSION ON (B)(6) 2006 DUE TO VAGINAL MESH EROSION. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT REVISION OF MESH AND EXCISION OF SCAR TISSUE FROM RIGHT SUPRAPUBIC AREA ON (B)(6) 2007 DUE TO RIGHT SUPRAPUBIC TENDERNESS AND STATUS POST TENSION FREE VAGINAL SLING FOR INCONTINENCE (NON-HEALING WOUND). IT WAS REPORTED THAT PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS, TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, EXPLORATION OF THE RETROPUBIC SPACE WITH EXCISION OF THE RIGHT ARM OF PRIOR MESH MID-URETHRAL SLING AND CYSTOURETHROSCOPY ON (B)(6) 2011 DUE TO PELVIC PAIN, RIGHT SIDED PAIN AT THE SITE OF PRIOR MESH MID-URETHRAL SLING, LEFT ADNEXAL CYST AND RECURRENT STRESS URINARY INCONTINENCE

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 6/2/2016. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY RETENTION AND MILD HEMATURIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2006 AND TVT WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2007 BY DR. (B)(6).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS 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
    250784 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1353463

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention