BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH

    MDR report key: 5103500 · Received September 25, 2015

    Report

    Report Number
    3000302531-2015-00302
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    August 28, 2015
    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. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    NOSE BLED PROFUSELY (BOTH) INSIDE (AND OUT) [EPISTAXIS]. NOSE BLED PROFUSELY (BOTH INSIDE AND) OUT-SKIN [SKIN HAEMORRHAGE]. PLUNGED STEM THROUGH SIDE OF NOSE, AKIN TO A NOSE PIERCING [FACE INJURY]. NOSE IS TENDER [RHINALGIA]. CARTRIDGE DETACHED DURING BRUSHING, EXPOSING THE SHARP STEM THAT LENDS CONTROL TO CARTRIDGE [DEVICE BREAKAGE]. CARTRIDGE DETACHED FROM TOOTHBRUSH AND EXPOSED STEM PLUNGED THROUGH NOSE [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: A CONSUMER REPORTED THAT WHILE USING AN ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH ON (B)(6) 2015, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN DETACHED AND EXPOSED THE "SHARP STEM" THAT LENDS CONTROL TO THE BRUSH HEAD. THE REPORTER STATED THAT HE OR SHE SOMETIMES BRUSHES VIGOROUSLY WITH A SWEEPING MOTION. THE "SHARP STEM" PLUNGED THROUGH THE SIDE OF HIS OR HER NOSE ON THE ENSUING SWEEP. IT BLED PROFUSELY BOTH INSIDE AND OUT, AND THE NOSE WAS TENDER. THE CASE OUTCOME WAS NOT RECOVERED/ NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2015 RECEIVED FOLLOW-UP: THE CONSUMER REPORTED THAT THE INJURY WAS MINOR, AND AKIN TO A NOSE PIERCING. THE PRODUCT HAD BEEN USED FOR 9 YEARS, AND WORKED FINE. THE BRUSH HEAD WAS REPLACED, AND WAS HOLDING FIRM. THE REPORTER STATED THE CAUSE OF THE INJURY MIGHT HAVE BEEN THE ENERGETIC USE OF THE PRODUCT, AND HE OR SHE IS BRUSHING WITH GREATER CAUTION AND EASE. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2015 RECEIVED FOLLOW-UP: THE CONSUMER REPORTED THAT HE OR SHE WOULD NOT BE SENDING THE TOOTHBRUSH TO THE COMPANY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636270 ORAL-B PROFESSIONAL CARE RECHARGEABLE TOOTHBRUSH TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1