BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 7699276 · Received July 18, 2018

    Report

    Report Number
    3000302531-2018-00191
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Report Date
    June 21, 2018
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    15-AUG-2018 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED TOOTHBRUSH HEAD ON 14-AUG-2018. TOOTHBRUSH HEAD CONFIRMED TO BE COUNTERFEIT.

    Description of Event or Problem · 0

    NIPPED TONGUE [TONGUE INJURY]. NIPPED THE INNER SIDE OF CHEEK [MOUTH INJURY]. BRUSH HEAD BROKE...BRUSH HEAD NIPPING ON THE TONGUE OR CHEEK [INJURY ASSOCIATED WITH DEVICE]. SWALLOWED A SMALL SCREW FROM BRUSH HEAD [ACCIDENTAL DEVICE INGESTION]. INGESTED SCREW [EXPOSURE VIA INGESTION]. BRUSHHEAD BROKE [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: CONSUMER SENT E-MAIL REPORTING BRUSH HEADS BREAKING AS SHE BRUSHED HER TEETH, AND A LITTLE SCREW WAS SWALLOWED. NO SERIOUS INJURY REPORTED. FOLLOW-UP: CONSUMER REPORTED SHE PUT HER FINGERS DOWN HER THROAT TO THROW THE SCREW BACK UP, AND SHE WAS FINE.

    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.

    Description of Event or Problem · 1

    NIPPED TONGUE [TONGUE INJURY]. NIPPED THE INNER SIDE OF CHEEK [MOUTH INJURY]. BRUSH HEAD BROKE...BRUSH HEAD NIPPING ON THE TONGUE OR CHEEK [INJURY ASSOCIATED WITH DEVICE]. SWALLOWED A SMALL SCREW FROM BRUSH HEAD [ACCIDENTAL DEVICE INGESTION]. INGESTED SCREW [EXPOSURE VIA INGESTION]. BRUSHHEAD BROKE [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER SENT E-MAIL REPORTING BRUSH HEADS BREAKING AS SHE BRUSHED HER TEETH, AND A LITTLE SCREW WAS SWALLOWED. NO SERIOUS INJURY REPORTED. FOLLOW-UP: CONSUMER REPORTED SHE PUT HER FINGERS DOWN HER THROAT TO THROW THE SCREW BACK UP, AND SHE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540490 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN| ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN