BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 261617 · Received February 4, 2000

    Report

    Report Number
    1624487-2000-00002
    Event Type
    Other
    Date Received
    February 4, 2000
    Date of Event
    January 6, 2000
    Report Date
    February 2, 2000
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LGF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SAME HEALTH CARE PROFESSIONAL APPLIED THE SPLINTING SYSTEM USING THE SAME METHODS AS DESCRIBED IN THE NARRATIVE OF REPORT NUMBER 1624487-2000-00001. THE FAILURE TO FOLLOW THE INSTRUCTIONS AGAIN COULD HAVE BEEN THE CAUSE OF THIS INCIDENT AFTER THE SPLINT WAS APPLIED. AFTER THE SPLINT WAS REMOVED, A SLIGHT DISCOLORATION OF THE SKIN WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL UNIVERSAL SPLINTING SYSTEM LGF DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other