BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 1001078 · Received February 22, 2008

    Report

    Report Number
    2210968-2008-00100
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    January 24, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE IN 2007. ON APPROX THREE MONTHS LATER, THE PATIENT WAS FOUND TO HAVE DEVELOPED A MESH EROSION OF MODERATE INTENSITY. IT WAS PLANNED THAT THE PATIENT WOULD RETURN TO THE HOSPITAL FOR EXCISION OF THE MESH EROSION IN 2008.

    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 54 YR Required Intervention