BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 3 SHORT 18IN - 22IN

    MDR report key: 13358709 · Received January 26, 2022

    Report

    Report Number
    2028253-2022-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    November 16, 2021
    Report Date
    January 26, 2022
    Manufacturer
    BREG, INC.
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AWAITING PRODUCT RETURN FOR EVALUATION. A REVIEW OF INTERNAL FILES FROM DATE OF INCIDENT TO DATE OF THIS REPORT IDENTIFIED NO OTHER REPORTS FOR THIS ALLEGED INCIDENT. NO INJURY WAS REPORTED AND PATIENT HAS CONTINUED TO USE PRODUCT.

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED AND EVALUATED ON FEB 16, 2022, UNABLE TO CONFIRM REPORTED INCIDENT OR ROOT CAUSE AS PRODUCT WAS NOT RETURNED IN IT'S ORIGINAL CONDITION. NO ADDITIONAL SIGNS OF MALFUNCTION. A DHR REVIEW INDICATES PRODUCT MET ALL RELEASE REQUIREMENTS AND THERE WERE NO DEVIATIONS OR NONCONFORMANCES ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 0

    ON JANUARY 4, 2022 BREG INC. RECEIVED A MEDWATCH REPORT STATING: "STRAPS READILY DETACH, CAUSING BRACE LOOSENING, SLIPPAGE, POSING ACUTE RISK OF SLIP AND FALL." NO REPORTED INJURY ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 0

    ON JANUARY 4, 2022 BREG INC. RECEIVED A MEDWATCH REPORT STATING: "STRAPS READILY DETACH, CAUSING BRACE LOOSENING, SLIPPAGE, POSING ACUTE RISK OF SLIP AND FALL." NO REPORTED INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731425 REVOLUTION 3 SHORT 18IN - 22IN REVOLUTION 3 SHORT 18IN - 22IN ITQ BREG, INC. EK019003

    Patients

    Seq Age Sex Outcome Treatment
    1 Male