BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6134391 · Received November 30, 2016

    Report

    Report Number
    3000302531-2016-00471
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 3, 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

    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 RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED TWO TOOTHBRUSH HEADS ON (B)(6) 2016. TOOTHBRUSH HEADS CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    HEAD OF THE BRUSH AT THE BACK OF THROAT [FOREIGN BODY], HAVE A DETACHED BRUSH HEAD AT THE BACK OF MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON 03-NOV-2016 THAT LAST (B)(6), HE/SHE GOT THE HEAD OF THE ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN AT THE BACK OF HIS/HER THROAT. THE CONSUMER RECOUNTED THAT HE/SHE PURCHASED THE SET OF FOUR BRUSH HEADS ON (B)(6) 2016 AND PUT IT ON HIS/HER ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH THAT EVENING. NOW, MORE THAN 4 WEEKS LATER, HE/SHE HAD A DETACHED BRUSH HEAD AT THE BACK OF HIS/HER MOUTH, AND HE/SHE WONDERED WHAT IF IT HAD SHOT DOWN HIS/HER THROAT. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    HEAD OF THE BRUSH AT THE BACK OF THROAT [FOREIGN BODY]; HAVE A DETACHED BRUSH HEAD AT THE BACK OF MOUTH [DEVICE BREAKAGE]; PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2016 THAT LAST WEEKEND, HE/SHE GOT THE HEAD OF THE ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN AT THE BACK OF HIS/HER THROAT. THE CONSUMER RECOUNTED THAT HE/SHE PURCHASED THE SET OF FOUR BRUSH HEADS ON (B)(6) 2016 AND PUT IT ON HIS/HER ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH THAT EVENING. NOW, MORE THAN 4 WEEKS LATER, HE/SHE HAD A DETACHED BRUSH HEAD AT THE BACK OF HIS/HER MOUTH, AND HE/SHE WONDERED WHAT IF IT HAD SHOT DOWN HIS/HER THROAT. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787894 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH