BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3250109 · Received July 26, 2013

    Report

    Report Number
    2210968-2013-14709
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    September 12, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    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). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 BY (B)(6) DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL SALPINGO-OOPHORECTOMY.

    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) 2010 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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
    351344 GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 3068329

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention