BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET

    MDR report key: 19536312 · Received June 14, 2024

    Report

    Report Number
    3000302531-2024-00281
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Report Date
    August 19, 2024
    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

    14-AUG-2024 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

    STABBED IN THE NOSE - SKIN [SKIN INJURY], (STABBED IN THE NOSE) DRAWING BLOOD - SKIN [SKIN HAEMORRHAGE], BRUSH HEADS...KEEP COMING OFF AND DETACHING - ORAL-B [DEVICE BREAKAGE], NON P&G PRODUCT - ORAL-B [PRODUCT COUNTERFEIT]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEADS KEPT COMING OFF AND DETACHING WHILE THEY WERE BRUSHING WITH A BRAUN ORAL-B TOOTHBRUSH. THIS MORNING THEY STABBED THEMSELVES IN THE NOSE, DRAWING BLOOD. NO SERIOUS INJURY WAS REPORTED. 16-JUL-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 17-JUN-2024: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS DUAL ACTION EB417 BRUSH SET. NO SERIOUS INJURY WAS REPORTED. 16-JUL-2024 CASE UPDATE: THE CONCOMITANT PRODUCT LOT WAS 3DB14841333. NO SERIOUS INJURY WAS REPORTED. 14-AUG-2024 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

    STABBED IN THE NOSE - SKIN [SKIN INJURY]. (STABBED IN THE NOSE) DRAWING BLOOD - SKIN [SKIN HAEMORRHAGE]. BRUSH HEADS...KEEP COMING OFF AND DETACHING - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: CONSUMER VIA E-MAIL STATED THAT THE ORAL-B TOOTHBRUSH HEADS KEPT COMING OFF AND DETACHING WHILE THEY WERE BRUSHING WITH A BRAUN ORAL-B TOOTHBRUSH. THIS MORNING THEY STABBED THEMSELVES IN THE NOSE, DRAWING BLOOD. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168774 ORALBPWRORALCARERFLSDUALACTNEB417BRUSHSET TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD EB417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO| ORALBRCHGTOOTHBRUSHHANDLE3772 (ORAL-B/RECHARGEABLE