BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEROYAL

    MDR report key: 9246283 · Received October 28, 2019

    Report

    Report Number
    3010452421-2019-00002
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    September 5, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VOLUNTARY EVENT REPORT MW5089792 WAS RECEIVED BY DEROYAL INDUSTRIES, INC. ON 10/14/2019, INDICATING THE PATIENT BECAME AGITATED AND BROKE BILATERAL MEDICAL SOFT WRIST RESTRAINTS. THE EVENT WAS REPORTED AS A SERIOUS INJURY REQUIRING INTERVENTION. THE PART NUMBER WAS NOT PROVIDED WITHIN THE INITIAL REPORT. THE QUALITY ASSURANCE MANAGER FOR COMPLAINTS HAS MADE THREE ATTEMPTS TO THE CONTACT THE EMAIL ADDRESS THAT WAS PROVIDED, TO OBTAIN ADDITIONAL INFORMATION. THE EMAIL ATTEMPTS WERE MADE ON 10/14/2019, 10/16/2019 AND 10/22/2019. A VOICE MAIL ATTEMPT WAS ALSO MADE ON 10/14/2019, USING THE PHONE NUMBER THAT WAS PROVIDED IN THE INITIAL REPORT. THE PART NUMBER AND OR SAMPLE HAS NOT BEEN RECEIVED AT THIS TIME TO BE ABLE TO COMPLETE A THOROUGH INVESTIGATION. WE WERE UNABLE TO FIND EVIDENCE OF SHIPPING ANY PRODUCTS TO THE REPORTING CUSTOMER. ALSO, LISTED ON OUR INSTRUCTIONS FOR USE FOR OUR LIMB HOLDER ONE OF THE CONTRAINDICATIONS STATES - DO NOT USE ON A PATIENT WHO IS OR MAY BECOME HIGHLY AGGRESSIVE OR AGITATED. THE INVESTIGATION IS COMPLETE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT BECAME AGITATED AND BROKE BILATERAL MEDICAL SOFT WRIST RESTRAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038327 DEROYAL LIMB HOLDER FMQ ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention