BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 1173369 · Received September 22, 2008

    Report

    Report Number
    2210968-2008-00834
    Event Type
    Injury
    Date Received
    September 22, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 A PT UNDERWENT A TOTAL PELVIC FLOOR REPAIR PROCEDURE IN 2007. IN 2008, IT WAS NOTED THAT THE PT HAD AN ANTERIOR MESH EROSION. TOPICAL ESTROGEN CREAM WAS PRESCRIBED AS A RESULT. THE SURGEON HAS INDICATED THAT POSSIBLE SURGICAL INTERVENTION WILL BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3011877

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention