BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROTIP

    MDR report key: 491367 · Received October 22, 2003

    Report

    Report Number
    8021764-2003-00004
    Event Type
    Other
    Date Received
    October 22, 2003
    Date of Event
    August 13, 2003
    Report Date
    October 22, 2003
    Manufacturer
    OWEN MUMFORD, LTD.
    Product Code
    GXB
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEUROTIP WAS BEING USED TO ASSESS LOWER LIMB SENSATION. PT RETURNED TO CLINIC HALF AN HOUR LATER EXPERIENCING THE BEGINNING OF AN ALLERGIC REACTION. MFR WAS CONTACTED BY THE HEALTHCARE PROFESSIONAL IN CHARGE WHO WAS ADVISED OF THE MATERIAL QUANTITIES THAT MAKE UP THE CONTENT OF THE STEEL. IT WAS THEN MENTIONED BY CO'S 'NEW PRODUCT DESIGN MANAGER' THAT NICKEL COULD BE THE OFFENDING MATERIAL. IT WAS NOTED THAT THE PT HAS MANY ALLERGIES AND IS NOT KNOWN TO HAVE A SPECIFIC ALLERGY TO NICKEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROTIP NEUROLOGICAL EXAMINATION PIN GXB OWEN MUMFORD, LTD. * N0097

    Patients

    Seq Age Sex Outcome Treatment
    1 *