BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 3751 · Received April 16, 1993

    Report

    Report Number
    3751
    Event Type
    Injury
    Date Received
    April 16, 1993
    Date of Event
    November 17, 1992
    Report Date
    March 31, 1993
    Manufacturer
    TRANSIDYNE GENERAL CORP.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BASIC BURN CARE WAS RENDERED TO THE PATIENTS. THE INJURIES HEALED WITH NO KNOWN PERMANENT DAMAGE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN. RESULTS OF EVALUATION: MATED WITH INCOMPATIBLE EQUIPMENT. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HEEL WARMER, INFANT FMT TRANSIDYNE GENERAL CORP. N/A 10103

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention