BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRPWRORALCARERFLSPRECISIONCLEAN

    MDR report key: 7192903 · Received January 16, 2018

    Report

    Report Number
    3000302531-2018-00014
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Report Date
    December 17, 2017
    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 · 0

    01-FEB-2018 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED TOOTHBRUSH HEAD ON 24-JAN-2018. TOOTHBRUSH HEAD CONFIRMED COUNTERFEIT.

    Description of Event or Problem · 0

    LIP CAUGHT [LIP INJURY] HEADS OF THE BRUSHES LOOSE, LIP WOULD GET CAUGHT IN BETWEEN [INJURY ASSOCIATED WITH DEVICE] HEADS OF THE BRUSHES LOOSE, METAL PIN DETACHED- PRECISION CLEAN BRUSH HEADS [DEVICE BREAKAGE] PRODUCT COUNTERFEIT [PRODUCT COUNTERFEIT]. CASE DESCRIPTION: REPORT SOURCE: SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON 17-DEC-2017 THAT THE HEADS OF ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN WERE QUITE LOOSE, AND ONCE IN A WHILE HIS/HER LIP WOULD GET CAUGHT IN BETWEEN. THE CONSUMER REPORTED THAT THE METAL PIN BECAME DETACHED IN ONE OF THEM. THE CONSUMER STATED THIS HAD NEVER HAPPENED BEFORE, AND THE BRUSH WAS NOT WORN AND EXCESSIVE PRESSURE WAS NOT APPLIED. THE CASE OUTCOME WAS UNKNOWN. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    TURN 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

    LIP CAUGHT [LIP INJURY]. HEADS OF THE BRUSHES LOOSE, LIP WOULD GET CAUGHT IN BETWEEN [INJURY ASSOCIATED WITH DEVICE]. HEADS OF THE BRUSHES LOOSE, METAL PIN DETACHED- PRECISION CLEAN BRUSH HEADS [DEVICE BREAKAGE]. CASE DESCRIPTION: REPORT SOURCE: SPONTANEOUS. A CONSUMER OF UNSPECIFIED AGE AND GENDER REPORTED VIA E-MAIL ON (B)(6) 2017 THAT THE HEADS OF ORAL-B POWER ORAL CARE REFILLS PRECISION CLEAN WERE QUITE LOOSE, AND ONCE IN A WHILE HIS/HER LIP WOULD GET CAUGHT IN BETWEEN. THE CONSUMER REPORTED THAT THE METAL PIN BECAME DETACHED IN ONE OF THEM. THE CONSUMER STATED THIS HAD NEVER HAPPENED BEFORE, AND THE BRUSH WAS NOT WORN AND EXCESSIVE PRESSURE WAS NOT APPLIED. THE CASE OUTCOME WAS UNKNOWN. RELEVANT HISTORY: NONE REPORTED. CONCOMITANT PRODUCT: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41274 ORALBPWRPWRORALCARERFLSPRECISIONCLEAN TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD NOT AVAILABLE

    Patients

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