BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 5460411 · Received February 25, 2016

    Report

    Report Number
    1060680-2016-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2016
    Date of Event
    January 26, 2016
    Report Date
    February 23, 2016
    Manufacturer
    MEDI USA, L.P.
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE PRODUCT IS NOT MADE BY DEROYAL INDUSTRIES, INC. IT IS MADE BY MEDI USA, L.P. THIS PRODUCT IS NO LONGER SOLD BY DEROYAL. THE PRODUCT WAS NOT RETURNED TO DEROYAL, THEREFORE IT COULD NOT BE INSPECTED OR EVALUATED. REPLACEMENT PARTS WERE SENT TO THE INITIAL REPORTER, MR. (B)(6). THE CUSTOMER WAS SATISFIED THAT HE WOULD BE ABLE TO REPAIR BRACE WITH REPLACEMENT PARTS. CORRECTIONS: REPLACEMENT PARTS WERE SENT TO THE INITIAL REPORTER, MR. (B)(6). CUSTOMER SATISFIED THAT HE WOULD BE ABLE TO REPAIR BRACE WITH REPLACEMENT PARTS. CORRECTIVE ACTION: A SUPPLIER NOTIFICATION LETTER (SNL) WILL BE SENT OUT TO INFORM THE SUPPLIER OF THIS COMPLAINT. PREVENTIVE ACTION: THERE ARE NO PREVENTIVE ACTIONS NEEDED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COPIED BELOW ARE RESPONSES GIVEN BY THE INITIAL REPORTER TO THE DEROYAL COMPLAINT QUESTIONNAIRE. QUALITY ISSUE DETAILS: DATE OF OCCURRENCE: (B)(6) 2016. WHEN DID QUALITY ISSUE OCCUR? DURING USE. WHO WAS USING OR OPERATING THE PRODUCT WHEN THE QUALITY ISSUE OCCURRED? PATIENT/END CONSUMER. WAS A MEDICAL PROCEDURE INVOLVED? NO. NAME OF MEDICAL PROCEDURE: NOT APPLICABLE. DID THE QUALITY ISSUE CAUSE A DELAY IN THE MEDICAL PROCEDURE? NOT APPLICABLE. DETAILED DESCRIPTION OF QUALITY ISSUE: PT HAS RASH FROM BRACE WHERE THE VELCRO HAS COME APART. HOW WAS THE QUALITY ISSUE WAS IDENTIFIED? BY ACTUAL USE. HOW WAS THE PRODUCT BEING USED? AS DESCRIBED. WAS IT THE INITIAL USE OF THE PRODUCT? YES. WAS THE PRODUCT MODIFIED FROM THE ORIGINAL CONDITION SUPPLIED BY DEROYAL? NO. WAS THE PRODUCT CONNECTED TO OR USED IN CONJUNCTION WITH OTHER DEVICES OR OUTCOME DETAILS: OUTCOME(S) ATTRIBUTED TO QUALITY ISSUE: NONE. PERSON(S) AFFECTED BY OUTCOME(S) CHECKED ABOVE: PATIENT. KNOWN PRE-EXISTING CONDITION(S) OF PERSON(S) AFFECTED: NONE SPECIFIED. WAS THE INCIDENT REPORTED TO THE FDA? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116360 DEROYAL KNEE BRACE ITQ MEDI USA, L.P. 480-13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other