BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT COOL THUMB CMC RESTRICTION SPLINT

    MDR report key: 6982132 · Received October 26, 2017

    Report

    Report Number
    1000124207-2017-00006
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    August 25, 2016
    Report Date
    October 11, 2017
    Manufacturer
    NORTH CCOAST MEDICAL, INC.
    Product Code
    ILH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NORTH COAST MEDICAL BECAME AWARE OF THIS ISSUE ON (B)(4) 2017 FROM A REPORT BY: (B)(6) OF (B)(6) . THIS WAS AFTER (B)(4) OF (B)(4) SENT (B)(4) AN INCIDENT REPORT INVESTIGATION SCHEME, FILE REFERENCE: (B)(4). AFTER LEARNING OF THIS INCIDENT NORTH COAST MEDICAL, INC. PERFORMED A MATERIAL TEST ON A SAMPLE HAND SPLINT (PATIENT DID NOT RETURN THE ORIGINAL UNIT), AND THE TESTS CONCLUSION WAS "PASS".

    Description of Event or Problem · 1

    PATIENT EXPERIENCED AN ALLERGIC REACTION TO VELCRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759631 COMFORT COOL THUMB CMC RESTRICTION SPLINT COMFORT COOL ILH NORTH CCOAST MEDICAL, INC. NC79557 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other