BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEISTER MEDIZINTECHNIK/SOLD AS OPTIK, INC. HOOK ELECTRODE

    MDR report key: 1603 · Received November 3, 1992

    Report

    Report Number
    1122142-1992-00001
    Event Type
    Injury
    Date Received
    November 3, 1992
    Date of Event
    October 14, 1992
    Report Date
    October 19, 1992
    Manufacturer
    GEISTER MEDIZINTECHNIK
    Product Code
    GYA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, OCTOBER 15, I WAS NOTIFIED BY SALES REP. THAT A NURSE HAD AT A HOSPITAL WHILE OUR RT. ANGLE ELECTRODE. I CALLED THE HOSPITAL AND SPOKE TO THE NURSE, WHO SAID THAT LATE THE PREVIOUS DAY SHE WAS TESTING THE ELECTRODE BY HOOKING IT TO THEIR VALLEY GENERATOR AND ACTIVATED. SHE WAS GLOVED AND HAD SPREAD K-Y JELLY IN HER PALM. UPON ACTIVATION, SHE FELT THE CURRENT ENTER HER HAND AND MOVE UP HER ARM. SHE RECEIVED A BURN ON HER PALM WHICH CAUSED BLISTERING. SHE WAS TAKEN TO THE EMERGENCY ROOM AND RELEASEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEISTER MEDIZINTECHNIK/SOLD AS OPTIK, INC. HOOK ELECTRODE HOOK ELECTRODE GYA GEISTER MEDIZINTECHNIK 13-3051 (GEISTER) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention