BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH3738

    MDR report key: 6544678 · Received May 4, 2017

    Report

    Report Number
    3000302531-2017-00183
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Report Date
    April 6, 2017
    Manufacturer
    BRAUN GMBH WERK MARKTHEIDENFELD
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE REPORTER INFORMED THE COMPANY THAT THE PRODUCT WAS UNAVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    PUNCTURED SKIN - TOP LIP / JAB - TOP LIP [LIP INJURY]. BLEEDING - FROM PUNCTURE ON TOP LIP [LIP HAEMORRHAGE]. IT REALLY HURTS - LIP [LIP PAIN]. THE METAL SHAFT THAT EXTENDS FROM THE HANDLE JABBED LIP AND PUNCTURED SKIN, BLED FOR A LITTLE BIT [INJURY ASSOCIATED WITH DEVICE]. BRUSH HEADS COME OFF WHILE BRUSHING [DEVICE BREAKAGE]. CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED VIA PHONE ON (B)(6) 2017 THAT THE ORAL-B BRUSHHEAD, VERSION UNKNOWN FELL OFF OF HER ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE TRIUMPH 3738 AND THE METAL PIECE JABBED INTO HER LIP; SHE ASSERTED THAT IT REALLY HURT. SHE EXPLAINED THAT WITH THIS LAST PACK OF BRUSH HEADS THAT SHE PURCHASED, THEY CAME OFF OCCASIONALLY WHILE BRUSHING AND IMMEDIATELY FELL IN THE SINK. HOWEVER, THE LAST TIME THIS HAPPENED, THE METAL SHAFT THAT EXTENDED FROM THE HANDLE JABBED HER IN THE LIP AND PUNCTURED THE SKIN; IT BLED FOR A LITTLE BIT. SHE STATED THAT SHE WAS STILL USING HER TOOTHBRUSH, USING IT 2-3 TIMES A DAY. SHE APPLIED A STYPTIC PENCIL TO HELP RELIEVE THE PROBLEM, AND THE BLEEDING RECOVERED IMMEDIATELY AFTER DOING SO; THE PUNCTURED SKIN/JAB HAD IMPROVED. NO MEDICAL ATTENTION WAS SOUGHT. SHE NO LONGER HAD THE BRUSH HEADS AS SHE THREW THEM OUT. THE OVERALL CASE OUTCOME WAS IMPROVED. OTHER RELEVANT HISTORY: ALLERGIES - NONE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324675 ORALBPWRRCHGTOOTHBRUSHHANDLETRIUMPH3738 TOOTHBRUSH, POWERED JEQ BRAUN GMBH WERK MARKTHEIDENFELD 3738 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ORAL-B BRUSHHEADS, VERSION UNKNOWN