BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRORALCARERFLSULTCLEANUNKBRUSHSET4CT

    MDR report key: 24646745 · Received March 20, 2026

    Report

    Report Number
    3000302531-2026-00066
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    UDI-DI
    8700216194969
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    WOUNDS- MOUTH [MOUTH INJURY]. RASH- MOUTH [ORAL MUCOSAL ERUPTION]. GUM SENSITIVITY [GINGIVAL PAIN]. THE BRUSH HEADS WERE LOOSER IN MOUTH- ORAL-B POWER ORAL CARE REFILLS [DEVICE CONNECTION ISSUE]. [ORAL-B IO TOOTHBRUSHES] ARE THEY ORIGINAL? BECAUSE THEY DISCOLOR VERY QUICKLY [SUSPECTED COUNTERFEIT PRODUCT]. CASE NARRATIVE: CONSUMER STATED VIA PHONE THAT THE BRUSH HEADS WERE LOOSE IN MOUTH. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15496 ORALBPWRORALCARERFLSULTCLEANUNKBRUSHSET4CT TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD A1277 11:10 8700216194969

    Patients

    Seq Age Sex Outcome Treatment
    1