BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU

    MDR report key: 2826925 · Received November 5, 2012

    Report

    Report Number
    MW5027546
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    AMBU
    Product Code
    IKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AMBU NEUROLINE CONCENTRIC NEEDLE, 25X0.30 MM, LOT 13265461 NEEDLE CONSISTENTLY MAKES POOR CONTACT WITH NEEDLE HOLDER WIRE, CAUSING ARTIFACT THAT APPEARS TO BE A MYOGENIC SIGNAL, BUT IS ACTUALLY NOISE. CHANGING NEEDLES FROM THE SAME LOT, NEEDLE HOLDER EVEN A BRAND NEW ONE, GROUND ELECTRODE, ETC. HAS NO EFFECT. ONLY SHOVING THE NEEDLE INTO THE NEEDLE HOLDER AS I CAN CORRECT THE PROBLEM AND ALLOWS PROPER SIGNAL ACQUISITION. SENT SOME BACK TO MFR WITH THIS EXPLANATION, NO SUBSTANTIVE RESPONSE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU CONCENTRIC EMG NEEDLE IKT AMBU 74025-30/25 1326561

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other