BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK INFANT TEMPERATURE THERAPY 4X4

    MDR report key: 2968285 · Received January 5, 2006

    Report

    Report Number
    MW5029002
    Event Type
    Malfunction
    Date Received
    January 5, 2006
    Date of Event
    November 15, 2005
    Report Date
    January 3, 2006
    Manufacturer
    TYCO/KENDALL CHICOPEE DC
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS OUTLINED IN THE ORIGINAL REPORT, CUSTOMER REPORTED THAT A NURSE WAS ACTIVATING A HEEL WARMER WHEN IT BROKE AND SPLASHED IN HER EYES. THE INFANT PT WAS NOT AFFECTED. THE CUSTOMER REPORTED THAT THE NURSE SUSTAINED A WORKER'S COMP INJURY AND WAS TREATED IN THE EMERGENCY ROOM. THEY DID COPIOUS FLUSHING AND PUT HER ON OPHTHALMIC ANTIBIOTICS. KIMBERLY-CLARK CORP HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT ARE RELAYING INFO RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS. EMPLOY+ABILITY INC WAS NOTIFIED BY KIMBERLY-CLARK OF THE INCIDENT ON (B)(6) 2005. EMPLOY+ABILITY RECEIVED A SAMPLE ON (B)(6) 2005 AND AFTER REVIEWING SENT THE SAMPLE TO TYCO/KENDALL (B)(4) (THE MFR) ON (B)(6) 2005 FOR THEIR REVIEW. EMPLOY+ABILITY INC IS THE DISTRIBUTOR FOR THE INFANT HEEL WARMER. ALL PACKAGING WAS COMPLETED PER KIMBERLY-CLARK REQUIREMENTS. THE INFANT HEEL WARMER IS MFG BY TYCO/KENDALL AND THE ONE SAMPLE RECEIVED BY EMPLOY+ABILITY WAS FORWARDED TO THEIR ATTENTION. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK INFANT TEMPERATURE THERAPY 4X4 INFANT HEEL WARMER (CHEMICAL HEAT PACK) MPO TYCO/KENDALL CHICOPEE DC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1