BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEGADYNE MEDICAL PRODUCTS, INC.

    MDR report key: 55433 · Received October 3, 1996

    Report

    Report Number
    1721194-1996-00002
    Event Type
    Other
    Date Received
    October 3, 1996
    Date of Event
    January 1, 1996
    Report Date
    October 2, 1996
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOME UNITS OF DEVICE WERE MISLABELED. HOWEVER, ALL INSTRUCTIONS AND WARNINGS FOR THE DEVICE WERE PRESENT AND CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGADYNE MEDICAL PRODUCTS, INC. ELECTROSURGICAL IRRIGATION/ASPIRATION UNIT GEI MEGADYNE MEDICAL PRODUCTS 0055 2400

    Patients

    Seq Age Sex Outcome Treatment
    1 *