BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STETHOSCOPE (NURSES)

    MDR report key: 2031 · Received January 5, 1993

    Report

    Report Number
    2031
    Event Type
    Injury
    Date Received
    January 5, 1993
    Report Date
    December 2, 1992
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LDE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    STETHOSCOPE WAS PLACED ON TOP OF RADIANT WARMER. AFTER THE DELIVERY OF THE BABY, IT WAS HANDED TO THE NEONATALOGIST WHO EXAMINED THE BABY'S CHEST WITH IT. IT WAS HOT AND BURNED THE BABY'S SKIN. LEFT BLISTER ON LEFT SIDE OF CHESTINVALID 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO 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 STETHOSCOPE (NURSES) LDE BAXTER HEALTHCARE CORPORATION 30775-345

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention