BEUDAMED
    FDA Adverse Event Summary report: N

    TEMP-A-AWAY KIT (ORAL)

    MDR report key: 5529 · Received April 28, 1993

    Report

    Report Number
    5529
    Date Received
    April 28, 1993
    Date of Event
    March 28, 1993
    Manufacturer
    BECTON DICKINSON AND COMPNAY
    Product Code
    KPD
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PCT TOOK TEMPERATURE OF PATIENT. PATIENT BIT THE THERMOMETER AND INCURRED A SMALL CUT ON HIS TONGUE. ALL MERCURY REMAINED INTACT IN THE BULB OF THE THERMOMETER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMP-A-AWAY KIT (ORAL) KPD BECTON DICKINSON AND COMPNAY 3702

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Invalid Data