BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 4129307 · Received September 18, 2014

    Report

    Report Number
    3003753847-2014-00018
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 24, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO. LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS THE PRIVATE-LABEL DISTRIBUTOR AND INITIAL IMPORTER OF THE 69908FC COLD PACK, OWENS AND MINOR RECEIVED A REPORT FROM A HOSPITAL THAT A NURSE HAD SUFFERED A FIRST DEGREE BURN TO ONE OF HER EYES AFTER A COLD PACK HAD OPENED DURING ANOTHER NURSE'S ACTIVATION OF THE PACK. THE HOSPITAL REPORTED THAT THE NURSE ACTIVATING THE COLD PACK HAD NOT FOLLOWED INSTRUCTIONS ON THE PACK FOR ACTIVATION AND HAD ACTIVATED THE PACK BY POUNDING ON THE PACK WITH HER FIRST, CAUSING THE PACK TO OPEN. THE CONTENTS OF THE PACK CAME INTO DIRECT CONTACT WITH ANOTHER NURSE STANDING CLOSE BY. THE NURSE'S EYES WERE IMMEDIATELY RINSED AND SHE WENT TO THE HOSPITAL'S EMERGENCY DEPARTMENT. THE HOSPITAL REPORTED THAT THE NURSE HAS RECOVERED FROM THE EYE INJURY AND HAS BEEN CLEARED FOR WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579650 MEDICHOICE INSTANT COLD PACK, 89IMD IMD SHANGHAI INTCO MEDICAL SUPPLY CO. LTD. 69908FC 1304IC10A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention