BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 2040295 · Received April 5, 2011

    Report

    Report Number
    2210968-2011-00383
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/05/2011. (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 A PATIENT UNDERWENT A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE ON AN UNKNOWN DATE. AFTER FOUR WEEKS THE PATIENT WAS FINE AND THE MESH WAS IN PLACE. AT SIX TO EIGHT MONTHS POST OPERATIVELY, THE PATIENT PRESENTED WITH PROGRESSIVE PAIN. A RECTOVAGINAL EXAM REVEALED A HARD THICK RIDGE AT THE VAGINAL APEX, LIKE THE MESH ROLLED UP LIKE A WINDOW SHADE. THE PATIENT IS SCHEDULED FOR AN MRI. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL POLYMERIC FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention