BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONAIR

    MDR report key: 10828770 · Received November 12, 2020

    Report

    Report Number
    1222304-2020-00024
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 23, 2020
    Report Date
    April 28, 2021
    Manufacturer
    CONAIR CORPORATION
    Product Code
    MNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    11/12/2020: WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECEIVED THE DEVICE. 4/27/2021: PER THE FDA'S REQUEST, SUBMITTED A SUPPLEMENTAL MDR THAT DOES NOT INCLUDE THE AGE AND DOB. I ALSO NOTICED THE COMMON DEVICE NAME AND PRODUCT CODE WAS INCORRECT. I MADE THE CHANGE FROM A HEATING PAD (IRT) TO A BMI SCALE (MNW).

    Description of Event or Problem · 0

    ON (B)(6) 2020: THE CONSUMER ALLEGES THAT THE PRODUCT SHATTERED IN THE BATHROOM. THE CONSUMER HAD A LACERATION AS A RESULT. 4/27/2021: PER THE FDA'S REQUEST, SUBMITTED A SUPPLEMENTAL MDR THAT DOES NOT INCLUDE THE AGE AND DOB.

    Additional Manufacturer Narrative · 1

    ON 11/12/2020 - WE HAVE REQUETED THE DEVICE BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. TO DATE, WE HAVE NOT RECIEVED THE DEVICE.

    Description of Event or Problem · 1

    ON 11/10/2020 - THE CONSUMER ALLEGES THAT THE PRODUCT SHATTERED IN THE BATHROOM. THE CONSUMER HAD A LACERATION AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296686 CONAIR BMI SCALE MNW CONAIR CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other