BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6933798 · Received October 10, 2017

    Report

    Report Number
    3000302531-2017-00359
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Report Date
    September 10, 2017
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    CUT ON GUM [GINGIVAL INJURY]; NEARLY CHOKED [CHOKING SENSATION]; GUM IS SORE [GINGIVAL PAIN]; HEAD SNAPPED IN MOUTH, CUT THE INSIDE OF MOUTH, METAL STICKING OUT CUT GUM - ORAL-B PRECISION CLEAN [INJURY ASSOCIATED WITH DEVICE]; HEAD SNAPPED IN MOUTH, METAL STICKING OUT - ORAL-B PRECISION CLEAN [DEVICE BREAKAGE]. CASE DESCRIPTION: REPORT SOURCE: SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2017 THAT WHILE BRUSHING THAT MORNING WITH AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE HEAD OF THE ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEAD SNAPPED OFF IN HIS/HER MOUTH WHICH HE/SHE CHOKED ON. THE CONSUMER REPORTED THERE WAS ALSO METAL STICKING OUT WHICH CUT HIS/HER GUM. THE OUTCOME OF CHOKING WAS RECOVERED. THE OUTCOME OF CUT GUM WAS UNKNOWN. THE CASE OUTCOME WAS IMPROVED. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 CONSUMER FOLLOW-UP VIA PHONE: THE CONSUMER, A (B)(6) FEMALE, REPORTED THE BRUSH HEAD WAS AN ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN. SHE REPORTED IT SNAPPED IN HER MOUTH WHILE SHE WAS BRUSHING YESTERDAY, SHE NEARLY CHOKED, AND IT CUT THE INSIDE OF HER MOUTH. THE CONSUMER REPORTED SHE USED THE PRODUCT TWICE A DAY FOR ABOUT A MONTH UNTIL DISCONTINUING USE ON (B)(6) 2017. THE BRUSH HEAD WAS FROM A PACK OF 6, AND SHE HAD USED SOME FROM THE PACK THAT WERE OK. THE PRODUCT HAD NEVER BEEN DROPPED, AND IT PASSED THE SCRATCH TEST. SHE RINSED HER MOUTH OUT AS TREATMENT, AND DID NOT SEEK MEDICAL ATTENTION. THE CUT WAS IMPROVED, AND THE OUTCOME OF NEARLY CHOKED WAS RECOVERED. THE CASE OUTCOME REMAINED IMPROVED. RELEVANT HISTORY: NONE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2017 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER REPORTED HER GUM WAS STILL SORE. SHE REPORTED SHE NEARLY SWALLOWED THE BRUSH HEAD. THE OUTCOME OF SORE GUM WAS NOT RECOVERED/ NOT RESOLVED. THE CASE OUTCOME REMAINED IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718677 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR