BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 5775588 · Received July 7, 2016

    Report

    Report Number
    3000302531-2016-00313
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Report Date
    June 9, 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

    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 24-AUG-2016 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED ONE ORAL-B PRECISION CLEAN TOOTHBRUSH HEAD ON (B)(6) 2016. THE RESULT OF THE ANALYSIS DONE WITH THE CONSUMER RETURN SHOWED THAT CONSUMER HANDLING (EXTERNAL FORCE) LED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    HEAD OF THE TOOTHBRUSH BROKE IN MOUTH EXPOSING A METAL WIRE [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A PARENT REPORTED VIA E-MAIL ON 09-JUN-2016 THAT WHILE HER SON OF UNSPECIFIED AGE USED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN BROKE IN HIS MOUTH EXPOSING A METAL WIRE. NO SYMPTOMS DEVELOPED. 10-JUN-2016 RECEIVED FOLLOW-UP E-MAIL FROM REPORTER: THE REPORTER STATED THE TYPE OF BRUSH HEAD USED WAS AN ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN, AND SHE THOUGHT THE TOOTHBRUSH WAS AN ORAL-B PRO 2000. SHE REPORTED HER SON NORMALLY CHANGED THE BRUSH HEAD WHEN IT WAS LOOKING WORN, AND SHE DID NOT THINK THE PRODUCT HAD BEEN DROPPED. THE REPORTER STATED SHE STILL HAD THE BROKEN BRUSH HEAD. NO SYMPTOMS DEVELOPED.

    Description of Event or Problem · 1

    HEAD OF THE TOOTHBRUSH BROKE IN MOUTH EXPOSING A METAL WIRE [DEVICE BREAKAGE]; NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE DESCRIPTION: A PARENT REPORTED VIA E-MAIL ON (B)(6) 2016 THAT WHILE HER SON OF UNSPECIFIED AGE USED AN ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN BROKE IN HIS MOUTH EXPOSING A METAL WIRE. NO SYMPTOMS DEVELOPED. ON 10-JUN-2016 RECEIVED FOLLOW-UP E-MAIL FROM REPORTER: THE REPORTER STATED THE TYPE OF BRUSH HEAD USED WAS AN ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN, AND SHE THOUGHT THE TOOTHBRUSH WAS AN ORAL-B PRO 2000. SHE REPORTED HER SON NORMALLY CHANGED THE BRUSH HEAD WHEN IT WAS LOOKING WORN, AND SHE DID NOT THINK THE PRODUCT HAD BEEN DROPPED. THE REPORTER STATED SHE STILL HAD THE BROKEN BRUSH HEAD. NO SYMPTOMS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430923 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD

    Patients

    Seq Age Sex Outcome Treatment
    1