BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMFORT COOL THUMB CMC RESTRICTION SPLINT

    MDR report key: 2249630 · Received August 26, 2011

    Report

    Report Number
    2939821-2011-00010
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    May 21, 2009
    Report Date
    August 23, 2011
    Manufacturer
    SCOTT SPECIALITIES, INC.
    Product Code
    ILH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER GOT THE SPLINT FROM HIS DOCTORS OFFICE. CUSTOMER DEVELOPED A RASH AFTER WEARING THE CMC RESTRICTION SPLINT. 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 SCOTT SPECIALITIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other