BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONAIR CORPORATION

    MDR report key: 7046295 · Received November 20, 2017

    Report

    Report Number
    1222304-2017-00036
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 22, 2017
    Report Date
    October 26, 2017
    Manufacturer
    CONAIR CORPORATION
    Product Code
    MNW
    UDI-DI
    74108295156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/14/2017 - WE RECEIVED THE DEVICE FROM THE CONSUMER. THE DEVICE IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017: WE RECEIVED THE DEVICE FROM THE CONSUMER. THE DEVICE IS CURRENTLY UNDER INVESTIGATION. ON (B)(6) 2017 CAUSE: INTERNAL STRESS DURING SAFETY GLASS MANUFACTURING. CONDITION HAS BEEN INVESTIGATED AND DESCRIBED IN EARLIER REPORT. DURING THE GLASS MANUFACTURING PROCESS, A SMALL PERCENTAGE OF PRODUCT DEVELOPS INHERENT STRESS. THIS CAUSES THE GLASS TO BREAK WITHOUT NOTICE OR UNDER NORMAL USE CONDITIONS. THIS IS A TECHNOLOGY ISSUE THAT HAS YET TO BE RESOLVED 100%. OUR FAILURE RATE IS VERY LOW, 1 SCALE IN 10,000.

    Description of Event or Problem · 1

    ON 10/30/2017 - THE CONSUMER CLAIMS THAT PRODUCT SHATTERED. NO INJURIES OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 - THE CONSUMER CLAIMS THAT PRODUCT SHATTERED. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826375 CONAIR CORPORATION BMI SCALE MNW CONAIR CORPORATION WW707Y 74108295156

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other