BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRORALCARERFLSCROSSACTNEB50

    MDR report key: 21269283 · Received January 29, 2025

    Report

    Report Number
    3000302531-2025-00032
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Report Date
    January 27, 2025
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    UDI-DI
    004210201105091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

    Description of Event or Problem · 0

    JABBED IN THE LIPS [LIP INJURY]. HEADS COME OFF OF TOOTHBRUSH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEADS CAME OFF OF THE ORAL-B TOOTHBRUSH AND JABBED THEM IN THE LIPS. NO SERIOUS INJURY WAS REPORTED. 16-JAN-2025 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSSACTION EB50. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606887 ORALBPWRORALCARERFLSCROSSACTNEB50 TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD EB50 004210201105091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ORALBRCHGTOOTHBRUSHHANDLE3709VITALITY (ORAL-B/RECH