BEUDAMED
    FDA Adverse Event Other Summary report: N

    DESARA

    MDR report key: 1972819 · Received January 21, 2011

    Report

    Report Number
    3003990090-2011-00001
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    June 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    CALDERA MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K072456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DESARA MESH WAS IMPLANTED IN (B)(6) 2010. AT THE PATIENT'S 6 WEEK FOLLOW UP, THE SURGEON FOUND MESH EROSION. MESH WAS TRIMMED. AT NEXT FOLLOW UP, PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA MESH SLING IMPLANT FTL CALDERA MEDICAL CAL-DS01 30008

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other