BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALF IMPLANT

    MDR report key: 1811611 · Received August 12, 2010

    Report

    Report Number
    2031444-2008-00001
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    December 7, 2007
    Report Date
    May 7, 2008
    Manufacturer
    HANSON MEDICAL
    Product Code
    MIB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ABSCESS OF LEFT CALF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALF IMPLANT IMPLANT MIB HANSON MEDICAL NA 4028

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization