BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 6435591 · Received March 27, 2017

    Report

    Report Number
    3000302531-2017-00125
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Report Date
    February 26, 2017
    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 RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    ON 03-MAY-2017 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED ONE TOOTHBRUSH HEAD ON 20-APR-2017. TOOTHBRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 1

    COUGHED [COUGH]; METAL PEG OF THE UPPER SIDE BROKE OFF IN SON'S MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: A PARENT REPORTED VIA E-MAIL ON 26-FEB-2017 THAT THE ORAL-B BRUSH METAL PEG OF THE UPPER SIDE OF AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN BROKE OFF IN THE MOUTH OF HIS/HER SON OF UNSPECIFIED AGE; FORTUNATELY, HIS/HER SON WAS ABLE TO COUGH IT OUT. THE PARENT STATED THAT THE BRUSH HEAD WAS RECENTLY CHANGED. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. ON 27-FEB-2017 RECEIVED PARENT'S FOLLOW-UP E-MAIL: THE PARENT REPORTED THAT THE METAL PEG ENDED UP IN THE DRAIN BUT HE/SHE STILL HAD THE TOOTHBRUSH HEAD. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    COUGHED [COUGH], METAL PEG OF THE UPPER SIDE BROKE OFF IN SON'S MOUTH [DEVICE BREAKAGE], PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: A PARENT REPORTED VIA E-MAIL ON (B)(6) 2017 THAT THE ORAL-B BRUSH METAL PEG OF THE UPPER SIDE OF AN ORAL-B POWER ORAL CARE REFILL PRECISION CLEAN BROKE OFF IN THE MOUTH OF HIS/HER SON OF UNSPECIFIED AGE; FORTUNATELY, HIS/HER SON WAS ABLE TO COUGH IT OUT. THE PARENT STATED THAT THE BRUSH HEAD WAS RECENTLY CHANGED. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. ON 27-FEB-2017 RECEIVED PARENT'S FOLLOW-UP E-MAIL: THE PARENT REPORTED THAT THE METAL PEG ENDED UP IN THE DRAIN BUT HE/SHE STILL HAD THE TOOTHBRUSH HEAD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219784 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1