BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT HEEL WARMER W/TAPE 4X4

    MDR report key: 1974647 · Received January 13, 2011

    Report

    Report Number
    1423537-2011-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    November 13, 2010
    Report Date
    January 12, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR LOT V7C006 WAS INVESTIGATED. NO ISSUES WERE DOCUMENTED DURING MANUFACTURE. AS NO SAMPLES WERE PROVIDED, THE EXACT CAUSE OF THE DIFFICULTIES ENCOUNTERED CANNOT BE DETERMINED. UNDER ROUTINE PRODUCTION A SAMPLING OF THESE UNITS ARE TESTED FOR POUCH INTEGRITY AND THE PRODUCTION RUN IS NOT RELEASED UNTIL ALL ASPECTS OF PRODUCT QUALITY MEET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    PER THE FDA ADVERSE EVENT OR PRODUCT PROBLEM FORM, THE DIRECTOR OF THE FAMILY CARE CENTER REPORTED THAT THE HEEL WARMER WAS SQUEEZED PER INSTRUCTION AND THE HEEL PACK POPPED OPEN CAUSING A 1 CM CHEMICAL BURN ON THE INFANT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT HEEL WARMER W/TAPE 4X4 INFANT HEEL WARMER W/TAPE 4X4/ IMD MPO CARDINAL HEALTH 11460-010T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other