BEUDAMED
    FDA Adverse Event Summary report: N

    EVER-READY

    MDR report key: 244 · Received March 2, 1992

    Report

    Report Number
    244
    Date Received
    March 2, 1992
    Date of Event
    January 3, 1992
    Report Date
    February 7, 1992
    Manufacturer
    N/A
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LARYNQOSCOPE FAILED TO ILLUMINATE, "C" BATTERIES FOUND TO BE CORRODEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVER-READY BATTERY "C" N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Invalid Data