BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLD PACK, INSTANT, ACCUTHERM, 6

    MDR report key: 1354878 · Received January 6, 2009

    Report

    Report Number
    1417592-2008-00043
    Event Type
    Other
    Date Received
    January 6, 2009
    Date of Event
    November 24, 2008
    Report Date
    December 18, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A STAFF MEMBER WAS ACTIVATING THE COLD PACK WHEN IT EXPLODED, SENDING THE CONTENTS INTO THE STAFF MEMBER'S EYES. THE STAFF MEMBER WAS TAKEN TO THE HOSPITAL FOR EVALUATION. A CORNEAL BURN WAS DIAGNOSED. SHE WAS GIVEN OINTMENT FOR HER EYE, SEEN A COUPLE OF DAYS LATER, AND EVERYTHING WAS DETERMINED TO BE FINE. NO SAMPLE WAS SAVED FOR EVALUATION, AND NO LOT NUMBER WAS REPORTED. NO ONE WAS ABLE TO SAY WHERE THE RUPTURE WAS LOCATED ON THE PACK. WITHOUT A SAMPLE AND OTHER SPECIFIC DETAILS RELATED TO THE REPORTED RUPTURE, WE ARE UNABLE TO IDENTIFY A ROOT CAUSE. WE HAVE REVISED THE LABELING ON THE PRODUCT TO FURTHER CLARIFY THE ACTIVATION INSTRUCTIONS FOR THE END USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STAFF MEMBER WAS ACTIVATING A COLD PACK AND IT EXPLODED, SENDING THE CONTENTS INTO THE EYES OF THE INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD PACK, INSTANT, ACCUTHERM, 6 NONE IMD MEDLINE INDUSTRIES, INC. MDS138000 MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention