BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3222791 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-12972
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    April 22, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    DATE SENT TO THE FDA: 02/10/2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TVH, BILATERAL UTEROSACRAL SUSPENSION, AND CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE AND STAGE 3 POP.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED OVERACTIVE BLADDER, INTRINSIC URETHRAL SPHINCTER DEFICIENCY, URINARY LEAKAGE, DIFFICULTY EMPTYING HER BLADDER, CONSTIPATION, URINARY INCONTINENCE, URINARY TRACT INFECTION,FREQUENCY, AND URGENCY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2008 DUE TO PAIN AND SUI. (B)(4).

    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
    322617 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 1302688

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention