BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 5888543 · Received August 19, 2016

    Report

    Report Number
    3000302531-2016-00356
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Report Date
    July 21, 2016
    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

    REPORTER RETURNED 7 ORAL-B PRECISION CLEAN TOOTHBRUSH HEADS ON 21-JUL-2016. PRODUCT INVESTIGATION NOT YET INITIATED.

    Description of Event or Problem · 1

    SMALL PIECE OF METAL HAD COME OUT OF BRUSH HEAD, ON THE BACK OF THE HEAD THE PLASTIC CRACKED THE PIN HAS CAME OUT [DEVICE BREAKAGE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A FEMALE CONSUMER, AGE UNSPECIFIED, REPORTED VIA LETTER ON (B)(6) 2016 THAT A SMALL PIECE OF METAL HAD COME OUT OF AN ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN, AND THE PLASTIC ON THE BACK OF THE BRUSH HEAD WAS CRACKED AND THE PIN CAME OUT. NO SYMPTOMS DEVELOPED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542176 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1