BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3360044 · Received September 13, 2013

    Report

    Report Number
    1060680-2013-00006
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 20, 2013
    Manufacturer
    DEROYAL ESTONIA OU
    Product Code
    ILH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED DEVICE HAS NOT BEEN RETURNED AT THIS TIME. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS. THIS PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE BRACE MADE HER ARM BREAK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462173 DEROYAL SPLINT, HAND, AND COMPONENTS ILH DEROYAL ESTONIA OU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other