BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBRCHGTOOTHBRUSHHANDLE3772

    MDR report key: 18908723 · Received March 14, 2024

    Report

    Report Number
    3000302531-2024-00101
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Report Date
    March 14, 2024
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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

    FACE. BLOOD - SKIN [SKIN HAEMORRHAGE]. PAIN LIKE A NEEDLE WAS STUCK IN FACE - SKIN [PAIN OF SKIN] . SMALL RED MARK CHEEK - SKIN [MACULE]. SMALL RED MARK INSIDE THE MOUTH [ORAL MACULE] . BRUSH HEAD KEEP JABBING IN THE FACE...METAL PRONG THING JABBED OUTSIDE OF FACE - SKIN [SKIN INJURY]. BRUSH HEAD.CAME OUT IN MOUTH. COMING OFF. SLIPS OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: ADULT MALE CONSUMER VIA PHONE STATED THAT THE ORAL-B TOOTHBRUSH HEADS KEPT COMING OUT/COMING OFF/SLIPPING OFF OF THE ORAL-B TOOTHBRUSH, TYPE 3772, IN HIS MOUTH WHILE BRUSHING AND THE METAL PRONG THING JABBED HIM IN THE FACE. THERE WAS PAIN (FACE), A BIT OF BLOOD, AND A SMALL RED MARK ON HIS CHEEK AND THE INSIDE OF HIS MOUTH. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018788 ORALBRCHGTOOTHBRUSHHANDLE3772 TOOTHBRUSH, POWERED - JEQ JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ORALBPWRORALCARERFLS (ORAL-B/POWER ORAL CARE REFIL.