BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUBDERMAL NEEDLE PLATINA

    MDR report key: 22274 · Received June 7, 1995

    Report

    Report Number
    MW1006167
    Event Type
    Malfunction
    Date Received
    June 7, 1995
    Date of Event
    May 15, 1995
    Report Date
    May 23, 1995
    Manufacturer
    BIOMEDICAL DIV. NICOLET INSTRUMENTS
    Product Code
    IKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING THE LEFT GASTROCHEMIUS MUSCLE NEEDLE ELECTRODE, THE NEEDLE WAS ABSENT FROM THE END OF THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUBDERMAL NEEDLE PLATINA DISPOSABLE SUBDERMAL NEELDE PLATINA IKT BIOMEDICAL DIV. NICOLET INSTRUMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR