BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR. BROWNS STEAM SANITIZING BAG

    MDR report key: 18093386 · Received November 7, 2023

    Report

    Report Number
    MW5147894
    Event Type
    Injury
    Date Received
    November 7, 2023
    Report Date
    October 17, 2023
    Manufacturer
    HANDI-CRAFT COMPANY - SAINT LOUIS
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USING DR. BROWNS STEAM SANITIZING BAG TO SANITIZE BABY BOTTLE PARTS IN THE HOSPITAL SETTING. CLOSED BAG PER INSTRUCTIONS AND MICROWAVED AFTER ADDING BOTTLE PARTS AND WATER. UPON COMPLETION OF MICROWAVE TIME, PICKED UP BAG PER INSTRUCTIONS, CAREFULLY AVOIDING THE STEAM VENT, BUT TOP SPONTANEOUSLY POPPED OPEN WITH STEAM ESCAPING IN AN UNEXPECTED LOCATION, CAUSING A SECOND DEGREE STEAM BURN TO THE HAND. THE INSTRUCTIONS SAY TO CLOSE BAG SECURELY. PERSON AFFECTED BELIEVED THAT HAD BEEN DONE, BUT THERE IS NO WAY TO VISUALLY VERIFY THAT THE SEAL IS COMPLETE AND/OR WILL REMAIN INTACT AT THE TIME THE BAG IS REMOVED FROM THE MICROWAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104136 DR. BROWNS STEAM SANITIZING BAG STERILIZER, STEAM FLE HANDI-CRAFT COMPANY - SAINT LOUIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other