BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT HEEL WARMER

    MDR report key: 5647059 · Received May 11, 2016

    Report

    Report Number
    1417592-2016-00057
    Event Type
    Injury
    Date Received
    May 11, 2016
    Report Date
    May 11, 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 PATIENT SUFFERED A BURN AFTER THE INFANT HEEL WARMER WAS APPLIED. WE HAVE NOT BEEN ABLE TO CONFIRM THIS REPORTED INJURY OR THAT IT WAS A MEDLINE DEVICE. WE HAVE RECEIVED VERY LITTLE INFORMATION FROM THE ACCOUNT REGARDING THIS INCIDENT. THE EXTENT OF THE INJURY OR IF ANY MEDICAL TREATMENT WAS PROVIDED IS UNKNOWN. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION. WE TESTED THE TEMPERATURE AFTER ACTIVATION USING RETAINED SAMPLES OF A DIFFERENT LOT AND ALL OF THE RESULTS WERE WITHIN SPECIFICATIONS. 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 AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A BURN AFTER THE INFANT HEEL WARMER WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302898 INFANT HEEL WARMER MPO RAPID AID CORP. CN152208A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other