BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT HEEL WARMER

    MDR report key: 5471813 · Received March 1, 2016

    Report

    Report Number
    1417592-2016-00016
    Event Type
    Injury
    Date Received
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    RAPID AID CORP.
    Product Code
    MPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A BABY SUFFERED A BURN ON THEIR HEEL AND BIG TOE AFTER PLACING AN INFANT HEEL WARMER ON IT. IT IS UNKNOWN HOW LONG IT WAS IN PLACE. IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS PROVIDED. MINIMAL DETAILS WERE PROVIDED BY THE ACCOUNT. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THIS DEVICE IS MANUFACTURED BY RAPID AID CORP. FOR MEDLINE. RAPID AID HAS BEEN NOTIFIED OF THIS INCIDENT. WE HAVE NOT IDENTIFIED A ROOT CAUSE BUT DUE TO THE REPORTED INJURY, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    A BABY SUFFERED A BURN ON THEIR HEEL AND BIG TOE AFTER PLACING AN INFANT HEEL WARMER ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126947 INFANT HEEL WARMER MPO RAPID AID CORP. RD12RAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other