BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE RIGHT HAND SPLINT

    MDR report key: 7214970 · Received January 23, 2018

    Report

    Report Number
    MW5074772
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 23, 2018
    Manufacturer
    CORFLEX
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT HE USED A SPLINT ON HIS RIGHT HAND FOR A FRACTURE ON (B)(6) 2016. A WEEK LATER WHEN THE SPLINT WAS REMOVED HE IMMEDIATELY HAD A RASH, BLISTER AND INTENSE ITCHING THAT WOULD HAVE KILLED A LESS SENSITIVE PERSON. THE ORTHOPEDIST AND 2 DERMATOLOGISTS DID NOT KNOW THAT THIS WAS A REACTION TO THE SPLINT AND DID NOT KNOW HOW TO TREAT IT. LAST WEEK DR. (B)(6) DERMATOLOGIST IN (B)(6) DIAGNOSED IT AS AN INFECTION SIMILAR TO (B)(6) AND STARTED TREATMENT. REPORTER IS CONCERNED THAT PRODUCT HAS MADE IN (B)(6) ON THE BOX AND IT CAN BE USED AS A WEAPON, THEREFORE, THE TSA AND NASA SHOULD BE INFORMED. HE INFORMED THE (B)(6). (B)(6) ALREADY HAD A SIMILAR OUTBREAK IN AN (B)(6) SCHOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56753 CE RIGHT HAND SPLINT SPLINT IQI CORFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR