BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRRCHGTOOTHBRUSHHANDLE3765

    MDR report key: 12736724 · Received November 2, 2021

    Report

    Report Number
    3000302531-2021-00340
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    October 10, 2021
    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

    13-DEC-2021 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND INVESTIGATED. PRODUCT INVESTIGATION RESULTS SHOWED THAT THE COMPLAINT IS CAUSED BY WEAR OF THE DRIVING SHAFT DUE TO USAGE OF ABRASIVE TOOTHPASTE IN COMBINATION WITH INSUFFICIENT CLEANING WITH USE OVER MANY YEARS.

    Additional Manufacturer Narrative · 0

    PRODUCT RETURN WAS REQUESTED BUT NOT RECEIVED SO FAR. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

    Description of Event or Problem · 0

    METAL WHERE THE HEAD ATTACHES IS STILL RUNNING AND WILL JAB INTO CHEEK [MOUTH INJURY]. TOOTHBRUSH HEADS KEEP POPPING OFF WHILE USING - ORAL-B [DEVICE BREAKAGE]. CONSUMER VIA E-MAIL STATED THAT THE TOOTHBRUSH HEADS ON THEIR GENIUS 6000 KEPT POPPING OFF WHILE USING. THE METAL WHERE THE HEAD ATTACHED WAS STILL RUNNING AND JABBED INTO THEIR CHEEK. NO SERIOUS INJURY WAS REPORTED. 08-NOV-2021 CASE UPDATE: CONCOMITANT PRODUCT UPDATED TO ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE 3765. NO SERIOUS INJURY WAS REPORTED. 13-DEC-2021 CASE UPDATE: SUSPECT PRODUCT UPDATED TO ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE 3765. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 0

    METAL WHERE THE HEAD ATTACHES IS STILL RUNNING AND WILL JAB INTO CHEEK [MOUTH INJURY] TOOTHBRUSH HEADS KEEP POPPING OFF WHILE USING - ORAL-B [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER VIA E-MAIL STATED THAT THE TOOTHBRUSH HEADS ON THEIR GENIUS 6000 KEPT POPPING OFF WHILE USING. THE METAL WHERE THE HEAD ATTACHED WAS STILL RUNNING AND JABBED INTO THEIR CHEEK. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634378 ORALBPWRRCHGTOOTHBRUSHHANDLE3765 TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3765 NOT AVAILABLE

    Patients

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