BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE

    MDR report key: 5022294 · Received August 13, 2015

    Report

    Report Number
    3003753847-2015-00002
    Event Type
    Injury
    Date Received
    August 13, 2015
    Report Date
    August 7, 2015
    Manufacturer
    SHIANGHAI INTCO MEDICAL SUPPLY CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4), THE INITIAL IMPORTER AND PRIVATE-LABEL DISTRIBUTOR OF THE MEDICHOICE INSTANT COLD COMPRESS, RECEIVED AN ADVERSE EVENT AND PRODUCT PROBLEM REPORT FROM AN END USER. THE END USER REPORTED THAT SHE RECEIVED A MEDICHOICE INSTANT COLD COMPRESS FROM HER PHYSICIAN FOLLOWING AN INJECTION IN HER BACK TO ADDRESS ONGOING BACK PAIN. THE END USER REPORTED THAT SHE APPLIED THE PRODUCT AS DIRECTED BUT IMMEDIATELY BEGAN TO FEEL PAIN AND DISCOMFORT. THE END USER REPORTED THAT THE AREA WHERE SHE HAD APPLIED THE COLD COMPRESS WAS BRIGHT RED AND BLISTERED THE FOLLOWING DAY. A PHYSICIAN TREATED THE AREA WITH OINTMENT, BUT IT CONTINUED TO BLISTER AND DID NOT HEAL. THE END USER REPORTED THAT A SKIN SPECIALIST HAS DIAGNOSED THE END USER WITH SECOND DEGREE BURNS THAT WILL REQUIRE SKIN GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535821 MEDICHOICE INSTANT COLD COMPRESS IMD SHIANGHAI INTCO MEDICAL SUPPLY CO., LTD. 69904 1408C04A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention