BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBRCHGTOOTHBRUSHHANDLE3767

    MDR report key: 19920360 · Received August 6, 2024

    Report

    Report Number
    3000302531-2024-00386
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Report Date
    March 5, 2025
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    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 NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

    Additional Manufacturer Narrative · 0

    13-FEB-2025 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.

    Description of Event or Problem · 0

    RAM THE METAL PIN INTO MY FACE- SKIN [SKIN INJURY]. BRUSH HEADS [...] FALL OFF OF THE TOOTHBRUSH OR GET STUCK IN YOUR MOUTH WHEN BRUSHING / SLIPS - ORAL-B [DEVICE BREAKAGE]. BRUSH HEADS SUDDENLY SIT QUITE LOOSELY ON THE HAND PIECE OF THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B PRECISION CLEAN TOOTHBRUSH HEADS SAT LOOSELY ON THE HAND PIECE OF THE ORAL-B TOOTHBRUSH, FELL OFF OF THE TOOTHBRUSH, AND GOT STUCK IN HIS MOUTH WHILE BRUSHING. NO INJURY WAS REPORTED. 24-JUL-2024 VIA IMAGES: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20 BRUSH SET 5CT AND LOT NUMBER WAS 4704132-00. THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3767 AND LOT NUMBER WAS 5BB80510201. NO INJURY WAS REPORTED. 24-JUL-2024 FOLLOW-UP VIA E-MAIL: CONSUMER REPORTED THAT THE TOOTHBRUSH SLIPPED AND THE METAL PIN RAMMED INTO HIS FACE. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    RAM THE METAL PIN INTO MY FACE- SKIN [SKIN INJURY]. BRUSH HEADS [...] FALL OFF OF THE TOOTHBRUSH OR GET STUCK IN YOUR MOUTH WHEN BRUSHING / SLIPS - ORAL-B [DEVICE BREAKAGE]. BRUSH HEADS SUDDENLY SIT QUITE LOOSELY ON THE HAND PIECE OF THE TOOTHBRUSH - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: MALE CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B PRECISION CLEAN TOOTHBRUSH HEADS SAT LOOSELY ON THE HAND PIECE OF THE ORAL-B TOOTHBRUSH, FELL OFF OF THE TOOTHBRUSH, AND GOT STUCK IN HIS MOUTH WHILE BRUSHING. NO SERIOUS INJURY WAS REPORTED. 24-JUL-2024 VIA IMAGES: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20 BRUSH SET 5CT AND LOT NUMBER WAS 4704132-00. THE CONCOMITANT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3767 AND LOT NUMBER WAS 5BB80510201. NO SERIOUS INJURY WAS REPORTED. 24-JUL-2024 FOLLOW-UP VIA E-MAIL: CONSUMER REPORTED THAT THE TOOTHBRUSH SLIPPED AND THE METAL PIN RAMMED INTO HIS FACE. NO SERIOUS INJURY WAS REPORTED. 13-FEB-2025 CASE UPDATE FROM INFORMATION INITIALLY LEARNED ON 07-JAN-2025: THE SUSPECT PRODUCT LOT NUMBER WAS H8356 H8355 4704132-00. NO SERIOUS INJURY WAS REPORTED. 13-FEB-2025 PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 3767. THE CONCOMITANT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN EB20 BRUSH SET 5CT. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572894 ORALBRCHGTOOTHBRUSHHANDLE3767 TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3767 5BB80510201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION 3767 (ALL| ORALBPWRORALCARERFLSPRECISIONCLEANEB20BRUSHSET5CT