BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORCURON

    MDR report key: 222683 · Received May 11, 1999

    Report

    Report Number
    222683
    Event Type
    Malfunction
    Date Received
    May 11, 1999
    Date of Event
    April 29, 1999
    Report Date
    May 7, 1999
    Manufacturer
    NEUROTECHNOLOGY
    Product Code
    BXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NERVE STIMULATOR UNDER PROXIMAL LEAD NOTED DIME SIZE AREA OF REDNESS AND BLISTER/BURN-LIKE APPEARING. MONITORED FOR FURTHER SKIN BREAKDOWN. APPLIED BACTRIM OINTMENT TO AREA. PT PARALYZED ON RESPIRATOR DUE TO CHRONIC ILLNESS. NERVE STIMULATOR USED TO ASSESS DEGREE OF PARALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORCURON NERVE STIMULATOR BXN NEUROTECHNOLOGY MOCROSTIN PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other