BEUDAMED
    FDA Adverse Event Other Summary report: N

    PNEUMATIC LITHITRIPTER

    MDR report key: 4834679 · Received June 1, 2015

    Report

    Report Number
    MW5042988
    Event Type
    Other
    Date Received
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    COOK MEDICAL
    Product Code
    FFK
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPANY DOES NOT HAVE PROPER IFU'S FOR STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354139 PNEUMATIC LITHITRIPTER FFK COOK MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1