BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 19655375 · Received July 2, 2024

    Report

    Report Number
    3000302531-2024-00293
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2024 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.

    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

    GREY METAL PIECES COMING OUT OF BRUSH HEADS. PRECISION CLEAN AND THE PIECES FALL INTO MOUTH...SWALLOWED SOME - ORAL-B [ACCIDENTAL DEVICE INGESTION] . GREY METAL PIECES COMING OUT OF BRUSH HEADS. SWALLOWED SOME [EXPOSURE VIA INGESTION] . GREY METAL PIECES COMING OUT OF BRUSH HEADS - ORAL-B [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT THE GREY METAL PIECES CAME OUT OF THEIR ORAL-B PRECISION CLEAN TOOTHBRUSH HEADS AND THE PIECES FELL INTO THEIR MOUTH. THEY MAY HAVE SWALLOWED SOME. NO INJURY WAS REPORTED. (B)(6) 2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 09-JUL-2024: THE SUSPECT PRODUCT LOT WAS I0074. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    GREY METAL PIECES COMING OUT OF BRUSH HEADS...PRECISION CLEAN AND THE PIECES FALL INTO MOUTH...SWALLOWED SOME - ORAL-B [ACCIDENTAL DEVICE INGESTION] GREY METAL PIECES COMING OUT OF BRUSH HEADS...SWALLOWED SOME [EXPOSURE VIA INGESTION] GREY METAL PIECES COMING OUT OF BRUSH HEADS - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA PHONE STATED THAT THE GREY METAL PIECES CAME OUT OF THEIR ORAL-B PRECISION CLEAN TOOTHBRUSH HEADS AND THE PIECES FELL INTO THEIR MOUTH. THEY MAY HAVE SWALLOWED SOME. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760784 ORALBPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD I0074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A| ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A