BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOF-GUARD

    MDR report key: 27519 · Received October 30, 1995

    Report

    Report Number
    MW1007469
    Event Type
    Other
    Date Received
    October 30, 1995
    Date of Event
    September 26, 1995
    Report Date
    October 11, 1995
    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 NERVE. STIMULATOR LEFT VOLAR SURFACE UPPER EXTREMITY AT THE WRIST, HAD MINOR INJURY SECONDARY TO THE DEVICE. SEVERAL SMALL PETECHIAE NOTED. SHE HAD UNDERGONE ULNAR NERVE STIMULATOR INTERMITTENTLY FOR 5 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 37 YR Other