BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE, TRIUMPH 3745

    MDR report key: 5074190 · Received September 14, 2015

    Report

    Report Number
    3000302531-2015-00289
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    August 17, 2015
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT

    Description of Event or Problem · 1

    JABBING/POKING CHEEK [MOUTH INJURY]. CHEEK RED [ORAL MUCOSAL ERYTHEMA]. JABBING/POKING CHEEK WITH METAL SHAFT OF TOOTHBRUSH [INJURY ASSOCIATED WITH DEVICE]. BRUSHHEAD IS LOOSE [DEVICE CONNECTION ISSUE]. BRUSHHEAD COMES OFF IN MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: A (B)(6) FEMALE REPORTED USE OF AN ORAL-B DEEP SWEEP BRUSHHEAD WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE, TRIUMPH 3745 AND THE BRUSHHEAD CAME LOOSE, WOULD NOT STAY ON AND EXPOSED THE TOOTHBRUSH HANDLES METAL SHAFT. THE CONSUMER REPORTED WHILE BRUSHING THE BRUSHHEAD COMES OFF IN HER MOUTH AND THE METAL SHAFT JABS AND POKES HER CHEEK. THE CONSUMERS CHEEK BECOMES RED WHICH RECOVERS WITHIN 2 HOURS. NO TREATMENT WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605522 ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE, TRIUMPH 3745 POWERED TOOTHBRUSH JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3745

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR