BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBRCHGTOOTHBRUSHHANDLE3770IOSRS2IO2IOS2D.2ZZ9.0

    MDR report key: 23941921 · Received January 2, 2026

    Report

    Report Number
    3000302531-2025-00584
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Report Date
    March 19, 2026
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 0

    05-MAR-2026 - PRODUCT INVESTIGATION RESULTS - PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 0

    GUM PAIN [GINGIVAL PAIN] STABBED MYSELF IN THE GUM [GINGIVAL INJURY] TOOTHBRUSH DON'T CHARGE...GREEN LIGHT COMES ON AND GOES OFF...LEAVE THEM OVERNIGHT AND THE RED LIGHT FLASHES STRAIGHT AWAY - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE POWER SOURCE ISSUE] TOOTHBRUSH HEADS FELL OFF - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER WAS CONTACTED VIA PHONE AND STATED THAT TOOTHBRUSH DID NOT CHARGE, THE GREEN LIGHT CAME ON AND THEN WENT OFF, AND WHEN LEFT OVERNIGHT THE RED LIGHT FLASHED IMMEDIATELY. THE HEADS IT CAME WITH ALSO FELL OFF, AND THEY STABBED THEIR GUM WHEN ONE CAME OFF. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    GUM PAIN [GINGIVAL PAIN]. STABBED MYSELF IN THE GUM [GINGIVAL INJURY]. TOOTHBRUSH DON'T CHARGE...GREEN LIGHT COMES ON AND GOES OFF...LEAVE THEM OVERNIGHT AND THE RED LIGHT FLASHES STRAIGHT AWAY - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE POWER SOURCE ISSUE]. TOOTHBRUSH HEADS FELL OFF - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER WAS CONTACTED VIA PHONE AND STATED THAT TOOTHBRUSH DID NOT CHARGE, THE GREEN LIGHT CAME ON AND THEN WENT OFF, AND WHEN LEFT OVERNIGHT THE RED LIGHT FLASHED IMMEDIATELY. THE HEADS IT CAME WITH ALSO FELL OFF, AND THEY STABBED THEIR GUM WHEN ONE CAME OFF. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP RECEIVED ON 05-MAR-2026: PRODUCT INVESTIGATION RESULTS: NO MANUFACTURING CAUSE AND NO DESIGN ISSUE IDENTIFIED BASED ON INVESTIGATION. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4187 ORALBRCHGTOOTHBRUSHHANDLE3770IOSRS2IO2IOS2D.2ZZ9.0 TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3770 BA51721557

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female ORALBPWRORALCARERFLSIOSRS (ORAL-B/POWER ORAL CARE.| ORALBPWRORALCARERFLSIOSRS (ORAL-B/POWER ORAL CARE.| ORALBRCHGTOOTHBRUSHHANDLE3770 (ORAL-B/RECHARGEABLE.| ORALBRCHGTOOTHBRUSHHANDLE3770 (ORAL-B/RECHARGEABLE.