BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMFORT COOL THUMB CMC RESTRICTION SPLINT

    MDR report key: 2331776 · Received November 9, 2011

    Report

    Report Number
    2939821-2011-00015
    Event Type
    Other
    Date Received
    November 9, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 22, 2011
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    ILH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WORE THIS SPLINT TWO TIMES. EACH TIME HE WORE THE SPLINT HE BROKE INTO A RASH ON THE TOP OF HIS HAND AND AT THE TOP PART OF HIS THUMB. HE COULD NOT REMEMBER THE EXACT DATE HE WORE THE SPLINT BUT ONCE HE DISCONTINUED THE USE, THE RASH WOULD DISAPPEAR IN TWO DAYS. THE SPLINT IS A LATEX FREE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT COOL THUMB CMC RESTRICTION SPLINT THUMB CMC RESTRICTION SPLINT ILH NORTH COAST MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other