BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 6128488 · Received November 28, 2016

    Report

    Report Number
    3000302531-2016-00464
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Report Date
    October 30, 2016
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT WAS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ORAL-B BRUSH HEAD GOT STUCK IN BETWEEN TEETH AND INSIDE OF CHEEK [FOREIGN BODY]; ORAL B BRUSH HEAD WAS LOOSE, TOOTHBRUSH HANDLE IS NOT LOCKING THE TOOTHBRUSH HEAD INTO PLACE, THEY SLIP AND SLIDE RIGHT OFF THE SHAFT [DEVICE CONNECTION ISSUE]; WHILE BRUSHING ORAL-B BRUSH HEAD CAME OFF IN MOUTH / BRUSH HEAD WON'T STAY ON THE UNIT, COME OFF WITH EASE [DEVICE BREAKAGE]. CASE DESCRIPTION: A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2016 THAT HE/SHE HAD BEEN USING AN ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE PROFESSIONAL CARE 3728 MODEL D19.523.1 FOR THE PAST COUPLE OF YEARS, AND HE/SHE CHANGED THE ORAL-B BRUSHHEAD, VERSION UNKNOWN ON (B)(6) 2016 AND IT WOULDN'T STAY ON THE UNIT. THE CONSUMER ELABORATED THAT THERE WAS NO "SNAP OR CLICK" LIKE HE/SHE WAS USED TO HEARING. THE CONSUMER ASSERTED THAT HE/SHE WAS USING THE CORRECT BRUSH HEADS, AND HE/SHE JUST HAD THE HEAD COME OFF IN HIS/HER MOUTH WHILE BRUSHING AND ALMOST STABBED THE BACK OF HIS/HER THROAT WITH THE METAL TANG ON THE END OF THE HANDLE. THE CONSUMER NOTED THAT HE/SHE HAD TRIED SEVERAL OTHER BRUSH HEADS AND ALL CAME OFF WITH EASE. NO SYMPTOMS DEVELOPED. ON 04-NOV-2016 RECEIVED FOLLOW-UP E-MAIL FROM CONSUMER: THE CONSUMER RECOUNTED THAT THE BRUSH HEAD CAME OFF IN HIS/HER MOUTH, BUT THERE WAS NO DAMAGE DONE IN HIS/HER MOUTH. THE CONSUMER EXPLAINED THAT HE/SHE GOT HIS/HER TOOTHBRUSH HANDLE FROM A DENTIST OFFICE. NO FURTHER INFORMATION WAS PROVIDED. ON 04-NOV-2016 RECEIVED FOLLOW-UP PHONE CALL FROM CONSUMER: THE CONSUMER, A MALE, REPORTED THAT ABOUT A WEEK AGO HE REPLACED THE BRUSH HEAD AND IT WAS LOOSE ON HIS TOOTHBRUSH, NOT LOCKING ON. THE CONSUMER NOTED THAT HE TRIED SEVERAL BRUSH HEADS AND THEY DID NOT STAY ON. AS SUCH, WHILE BRUSHING, THE BRUSH HEAD CAME LOOSE/OFF AND GOT STUCK IN BETWEEN HIS TEETH AND THE INSIDE OF HIS CHEEK. THE CONSUMER DESCRIBED THAT THE STEEL TIP JAMMED/RAMMED INTO HIS UPPER LEFT MOLAR IN HIS MOUTH, BUT THERE WAS NO DAMAGE OR BLEEDING. THE CONSUMER REPORTED THAT THE BRUSH HEADS WERE FINE, BUT THE TOOTHBRUSH HANDLE WAS NOT LOCKING THE TOOTHBRUSH HEAD INTO PLACE. THE CONSUMER STATED THAT HE HAD AN APPOINTMENT RECENTLY AND SHE LOOKED AT IT AND SAID THAT SHE COULD NOT SEE ANY DAMAGE; HE HAD PURCHASED THIS TOOTHBRUSH ABOUT 3 YEARS AGO. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. ON 07-NOV-2016 RECEIVED FOLLOW-UP PHONE CALL FROM CONSUMER: THE CONSUMER REPORTED THAT, AS HE COULD HAVE DONE SOME SERIOUS DAMAGE TO HIMSELF, HIS DENTIST TOOK HIM IN TO SEE HIM FOR AN EMERGENCY VISIT TO MAKE SURE HE WAS OKAY. NO FURTHER INFORMATION WAS PROVIDED. ON 09-NOV-2016 RECEIVED FOLLOW-UP E-MAIL FROM CONSUMER: THE CONSUMER REPORTED THAT NONE OF THE BRUSH HEADS STAYED ON THE UNIT. NO FURTHER INFORMATION WAS PROVIDED. ON 29-NOV-2016 RECEIVED FOLLOW-UP E-MAIL FROM CONSUMER: THE CONSUMER ASSERTED THAT THIS WAS NOT A BRUSH HEAD ISSUE, BUT RATHER A HANDLE ISSUE. HE RECOUNTED THAT THE BRUSH HEAD CAME OFF IN HIS MOUTH DURING VIGOROUS BRUSHING, WHEN THE NEW HEAD WAS INSTALLED THEY SLIPPED AND SLID RIGHT OFF THE SHAFT WITH NOTHING LOCKING THEM IN PLACE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780957 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 ORALBPWRRCHGTOOTHBRUSHHANDLEPROFCARE3728MODELD19.5