BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3212827 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12563
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 11, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, CYSTOCELE, AND RECTOCELE. THE PATIENT EXPERIENCED BLADDER PERFORATION. ON (B)(6) 2007, THE PATIENT HAD CYSTOSCOPY AND PERIURETHRAL COLLAGEN INJECTIONS DUE TO STRESS URINARY INCONTINENCE, INTRINSIC SPHINCTER DEFICIENCY AND PAIN. ON (B)(6) 2009, THE PATIENT HAD MESH EXCISION DUE TO BLADDER OBSTRUCTION, STRESS URINARY INCONTINENCE AND MESH EROSION. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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

    DATE SENT TO THE FDA: 09/24/2015. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2015 DUE TO SUI, MESH EROSION AND CYSTOCELE. (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
    314425 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2936958

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention