BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS

    MDR report key: 7327598 · Received March 9, 2018

    Report

    Report Number
    3000302531-2018-00069
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Report Date
    February 12, 2018
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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.

    Additional Manufacturer Narrative · 1

    ON 21-MAR-2018 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED AN UNSPECIFIED NUMBER OF TOOTHBRUSH HEADS ON 20-MAR-2018. TOOTHBRUSH HEADS CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    SPINNING HEAD MOVED AROUND A BIT AND THEN COME OFF WHILE BRUSHING, BROKEN [DEVICE BREAKAGE], NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2018 THAT THE LAST FEW TIMES HE/SHE HAD SWITCHED THE ORAL-B BRUSHHEAD, VERSION UNKNOWN FOR A NEW ONE, THE SPINNING HEAD HAD AFTER APPROXIMATELY 2 WEEKS FIRST MOVED AROUND A BIT AND THEN COME OFF WHILE BRUSHING. THE CONSUMER REPORTED THE ORAL-B ELECTRIC TOOTHBRUSH HAD BEEN USED FOR A FEW YEARS, AND HAD WORKED WITHOUT INCIDENT. NO SYMPTOMS WERE REPORTED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2018 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER SUBMITTED PICTURES OF THE PRODUCT REVEALING THE BRUSH HEADS USED WERE ORAL-B FLEXISOFT. THE CONSUMER REPORTED THERE WERE 4 IN THE PACK, AND 2 HAD BROKEN. CONCOMITANT TOOTHBRUSH HANDLE WAS ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE VITALITY 3709. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SPINNING HEAD MOVED AROUND A BIT AND THEN COME OFF WHILE BRUSHING, BROKEN [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2018 THAT THE LAST FEW TIMES HE/SHE HAD SWITCHED THE ORAL-B BRUSHHEAD, VERSION UNKNOWN FOR A NEW ONE, THE SPINNING HEAD HAD AFTER APPROXIMATELY 2 WEEKS FIRST MOVED AROUND A BIT AND THEN COME OFF WHILE BRUSHING. THE CONSUMER REPORTED THE ORAL-B ELECTRIC TOOTHBRUSH HAD BEEN USED FOR A FEW YEARS, AND HAD WORKED WITHOUT INCIDENT. NO SYMPTOMS WERE REPORTED. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2018 CONSUMER FOLLOW-UP VIA E-MAIL: THE CONSUMER SUBMITTED PICTURES OF THE PRODUCT REVEALING THE BRUSH HEADS USED WERE ORAL-B FLEXISOFT. THE CONSUMER REPORTED THERE WERE 4 IN THE PACK, AND 2 HAD BROKEN. CONCOMITANT TOOTHBRUSH HANDLE WAS ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE VITALITY 3709. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172397 ORAL-B FLEXISOFT OR PRECISION CLEAN BRUSHHEADS TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1