BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRORALCARERFLS

    MDR report key: 21643134 · Received March 19, 2025

    Report

    Report Number
    3000302531-2025-00115
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 29-APR-2025 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.

    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 MYSELF IN THE FACE / POKES - FACE / HIT ME RIGHT UNDER THE EYE [FACE INJURY]. BRUSH HEAD IS NOT STAYING ON THE BRUSH - ORAL-B [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT - ORAL-B [PRODUCT COUNTERFEIT]. CASE NARRATIVE: CONSUMER VIA PHONE REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD WAS NOT STAYING ON THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3754 AND JABBED AND POKED THEM IN THE FACE. NO SERIOUS INJURY WAS REPORTED. 26-FEB-2025 FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 57-YEAR-OLD FEMALE. NO MEDICAL PROFESSIONAL WAS CONTACTED. REPORTED THAT THE BRUSH HEAD ALSO HIT HER UNDER THE EYE. NO SERIOUS INJURY WAS REPORTED. 29-APR-2025 PRODUCT INVESTIGATION RESULTS: THE PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE ORAL-B TOOTHBRUSH HEAD REFILL. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    JABBED MYSELF IN THE FACE/POKES: FACE/HIT ME RIGHT UNDER THE EYE [FACE INJURY]. BRUSH HEAD IS NOT STAYING ON THE BRUSH: ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD WAS NOT STAYING ON THE ORAL-B TOOTHBRUSH HANDLE, TYPE 3754 AND JABBED AND POKED THEM IN THE FACE. NO SERIOUS INJURY WAS REPORTED. ON 26-FEB-2025, FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 57-YEAR-OLD FEMALE. NO MEDICAL PROFESSIONAL WAS CONTACTED. REPORTED THAT THE BRUSH HEAD ALSO HIT HER UNDER THE EYE. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640387 ORALBPWRORALCARERFLS TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female ORALBRCHGTOOTHBRUSHHANDLE3754 (ORAL-B/RECHARGEABLE| ORALBRCHGTOOTHBRUSHHANDLE3754 (ORAL-B/RECHARGEABLE