BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3212731 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12551
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    April 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT FOLLOWING INSERTION OF MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, FISTULAE, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF MESH, REPAIR OF VESICOVAGINAL FISTULA TRANSVAGINALLY, KELLY PLICATION REPAIR OF CYSTOCELE, PARTIAL VAGINECTOMY AND CYSTOSCOPY WITH LEFT URETHRAL STENT PLACEMENT ON (B)(6) 2012 DUE TO MESH EROSION.

    Additional Manufacturer Narrative · 1

    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): 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 INTERNAL TISSUES, AND 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
    312465 GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2919415

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention