BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6158025 · Received December 9, 2016

    Report

    Report Number
    3000302531-2016-00482
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10-JAN-2017 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED TWO TOOTHBRUSH HEADS ON 29-NOV-2016. TOOTHBRUSH HEADS WERE IDENTIFIED TO BE ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN ON 13-DEC-2016. TOOTHBRUSH HEADS CONFIRMED TO BE COUNTERFEIT.

    Additional Manufacturer Narrative · 1

    RETURN OF PRODUCT HAS BEEN REQUESTED. REPORTER RETURNED 2 TOOTHBRUSH HEADS ON 29-NOV-2016. PRODUCT INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ORAL-B BRUSH HEAD DETACHED IN MOUTH [DEVICE BREAKAGE], NO ADVERSE EVENT [NO ADVERSE EVENT], PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA PHONE ON (B)(6) 2016 THAT AN ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEAD DETACHED IN HER MOUTH WHILE USED WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CONSUMER HAD PREVIOUSLY USED FLEXISOFT BRUSH HEADS. NO SYMPTOMS DEVELOPED.

    Description of Event or Problem · 1

    ORAL-B BRUSH HEAD DETACHED IN MOUTH [DEVICE BREAKAGE], NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA PHONE ON (B)(6) 2016 THAT AN ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEAD DETACHED IN HER MOUTH WHILE USED WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CONSUMER HAD PREVIOUSLY USED FLEXISOFT BRUSH HEADS. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815411 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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