BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRRCHGTOOTHBRUSHHANDLE3767SMART5000

    MDR report key: 16477547 · Received March 3, 2023

    Report

    Report Number
    3000302531-2023-00103
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Report Date
    April 13, 2023
    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

    ON 16-MAR-2023: 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

    BLOOD ON NOSE - SKIN [SKIN HAEMORRHAGE]. BLOOD ON LIP [LIP HAEMORRHAGE]. (STABBING TO) NOSE...PAINFUL - SKIN [PAIN OF SKIN] . (STABBING TO) LIP. PAINFUL [LIP PAIN] . STAB.(DRAWING BLOOD ON) NOSE. STABBING MARKS - SKIN [SKIN INJURY]. STAB...(DRAWING BLOOD ON) LIP. STABBING MARKS [LIP INJURY] . TOOTH BRUSH HEAD COMES OFF IN MOUTH - ORAL-B [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF IN THEIR MOUTH AND STABBED THEM, DRAWING BLOOD ON THEIR NOSE AND LIP. THE STABBING MARKS TO THEIR NOSE AND LIP WAS QUITE PAINFUL. NO SERIOUS INJURY WAS REPORTED. 16-FEB-2023 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT LOT WAS 5 BB 937 10701. THE CONCOMITANT PRODUCTS WERE: ORAL-B POWER POWER ORAL CARE REFILLS PRECISION CLEAN EB20 AND ORAL-B POWER POWER ORAL CARE REFILLS. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    BLOOD ON NOSE - SKIN [SKIN HAEMORRHAGE]. BLOOD ON LIP [LIP HAEMORRHAGE]. (STABBING TO) NOSE...PAINFUL - SKIN [PAIN OF SKIN]. (STABBING TO) LIP...PAINFUL [LIP PAIN]. STAB...(DRAWING BLOOD ON) NOSE...STABBING MARKS - SKIN [SKIN INJURY]. STAB...(DRAWING BLOOD ON) LIP...STABBING MARKS [LIP INJURY]. TOOTH BRUSH HEAD COMES OFF IN MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEAD CAME OFF IN THEIR MOUTH AND STABBED THEM, DRAWING BLOOD ON THEIR NOSE AND LIP. THE STABBING MARKS TO THEIR NOSE AND LIP WAS QUITE PAINFUL. NO SERIOUS INJURY WAS REPORTED. 16-FEB-2023 FOLLOW UP VIA E-MAIL: THE SUSPECT PRODUCT LOT WAS 5 BB 937 10701. THE CONCOMITANT PRODUCTS WERE: ORAL-B POWER POWER ORAL CARE REFILLS PRECISION CLEAN EB20 AND ORAL-B POWER POWER ORAL CARE REFILLS. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858076 ORALBPWRRCHGTOOTHBRUSHHANDLE3767SMART5000 TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3767 5 BB 937 10701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ORAL-B BRUSHHEADS, VERSION UNKNOWN (ALL OTHER NON-.| ORAL-B BRUSHHEADS, VERSION UNKNOWN (ALL OTHER NON-.| ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20 (ORAL-B.| ORALBPWRPWRORALCARERFLSPRECISIONCLEANEB20 (ORAL-B.