BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3211457 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12406
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    October 21, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO OVERACTIVE BLADDER, PROLAPSE, AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANOTHER MESH IMPLANTATION ON (B)(6) 2008 CONCURRENTLY WITH PREVIOUS MESH REVISION DUE TO STRESS URINARY INCONTINENCE AND ANTERIOR VAGINAL WALL MESH EXPOSURE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 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
    309382 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2980421

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention