BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3031935 · Received March 26, 2013

    Report

    Report Number
    3005225477-2013-00001
    Event Type
    Other
    Date Received
    March 26, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    LGF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE PATIENT REPORTED THE WRIST/FOREARM SPLINT CAUSED AN ALLERGIC REACTION. DEROYAL: PRODUCT INFORMATION WAS PULLED TO CONFIRM THAT THE MATERIAL THAT TOUCHES THE PATIENT IS A LATEX FREE, NON-TOXIC, NON-ALLERGENIC FOAM. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE WRIST/FOREARM SPLINT CAUSED AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123399 DEROYAL LGF DEROYAL GUATEMALA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other