BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUBDERMAL NEEDLE

    MDR report key: 84156 · Received April 16, 1997

    Report

    Report Number
    MW1011144
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    April 4, 1997
    Report Date
    April 7, 1997
    Manufacturer
    NICOLET BIOMEDICAL
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE ELECTRODE SEPARATED FROM HUB PORTION. HUB SHEATH CAME COMPLETELY OFF ELECTRODE FOLLOWING REMOVAL FROM PT'S LEFT WRIST, SUBDERMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUBDERMAL NEEDLE Implant SUBDERMAL NEEDLE GXY NICOLET BIOMEDICAL SET-#019-768900(B020) *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other