BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 6109922 · Received November 17, 2016

    Report

    Report Number
    1123071-2016-00002
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    ITQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FOR THIS QUALITY ISSUE HAS NOT BEEN RECEIVED FOR EVALUATION FROM THE CONSUMER. THE DEVICE IS EXPECTED TO BE RETURNED. UPON RECEIPT OF THE RETURNED PRODUCT, IT WILL BE TESTED AND EVALUATED. THERE WAS NO REPORT OF INJURY FROM THE PATIENT; IRRITATION, REACTION, RASH WERE NOT EXPERIENCED BY THE PATIENT. WE ARE UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME, DUE TO NO SAMPLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRAPS WERE BUNCHING UP AND CAUSING DISCOMFORT. A MEDICAL PROCEDURE WAS NOT INVOLVED. THE QUALITY ISSUE WAS IDENTIFIED DURING ACTUAL USE ON THE KNEE OF THE END USER. IT WAS THE INITIAL USE OF THE PRODUCT AND THE PRODUCT WAS NOT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY (B)(4). THE PRODUCT WAS NOT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR EQUIPMENT. A REPLACEMENT WAS GIVEN TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761825 DEROYAL KNEE BRACE ITQ DEROYAL INDUSTRIES, INC. KB9000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other