BEUDAMED
    FDA Adverse Event Summary report: N

    TOF-GUARD

    MDR report key: 29973 · Received February 8, 1996

    Report

    Report Number
    MW1008299
    Date Received
    February 8, 1996
    Date of Event
    January 8, 1996
    Report Date
    February 1, 1996
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SKIN UNDER PROXIMAL ELECTRODE OF PERIPHERAL LEFT NERVE STIMULATOR LEFT VOLAR SURFACE UPPER EXTREMITY AT THE WRIST HAD MINOR INJURY SECONDARY TO THE DEVICE. SEVERAL SMALL PETECHIAE NOTED. HE HAD UNDERGONE ULNAR NERVE STIMULATION INTERMITTENTLY FOR 4 DAYS MONITORING DEGREE OF NEUROMUSCULAR BLOCKADE BY STUDY DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOF-GUARD PERIPHERAL NERVE STIMULATOR GZI ORGANON TEKNIKA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR