BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL-B BRUSHHEADS, VERSION UNKNOWN

    MDR report key: 7250685 · Received February 8, 2018

    Report

    Report Number
    3000302531-2018-00041
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Report Date
    January 11, 2018
    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. THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT WAS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    BRUSHES GET LOOSE / BRUSH BECAME DETACHED, HAD BRUSH HEAD IN MOUTH DEVICE BREAKAGE. NO ADVERSE EVENT. CASE DESCRIPTION: REPORT SOURCE: NON-EVENT - SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON 11-JAN-2018 THAT THE BRUSHES OF THE ORAL-B BRUSHHEADS, VERSION UNKNOWN GOT LOOSE AFTER BRUSHING A FEW TIMES WITH THEM. THE CONSUMER ELABORATED THAT A BRUSH BECAME DETACHED LAST WEEKEND IN (B)(6) 2018 AND HE/SHE HAD THE BRUSH HEAD IN HIS/HER MOUTH. THE CONSUMER STATED THAT HE/SHE HAD PURCHASED ORAL-B TOOTHBRUSHES FOR YEARS. NO SYMPTOMS DEVELOPED. CONCOMITANT PRODUCT(S): ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101226 ORAL-B BRUSHHEADS, VERSION UNKNOWN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1