BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HL WMR 3. 5X5 W/TAB 25/B 100/C

    MDR report key: 3955752 · Received July 16, 2014

    Report

    Report Number
    1219103-2014-00016
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH THE HEEL WARMER. THE CUSTOMER REPORTS, THE INCIDENT OCCURRED IN A HOSPITAL (B)(6). THE CUSTOMER STATES, THE NURSE PICKED UP THE HEEL WARMER, WAS PROCEEDING TO WALK BACK TO THE INFANT, AND WITH VERY LITTLE PRESSURE TO ACTIVATE, THE HEEL WARMER EXPLODED IN THE NURSE'S FACE AND ON THE CEILING. THE INFANT WAS NOT HARMED. THE NURSE WAS SENT TO THE ER FOR MEDICAL TREATMENT. THE CUSTOMER REPORTS, THE NURSE WAS PRESCRIBED ERYTHROMYCIN FOR HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415909 HL WMR 3. 5X5 W/TAB 25/B 100/C HEEL WARMER MPO COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW MH00002T 321826X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK