• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD RALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BRAUN GMBH WERK MARKTHEIDENFELD RALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED Back to Search Results
Model Number 3765
Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This report is being filed due to an alleged fire incident that we could not investigate so far.We are reporting to the fda out of an abundance of caution.The product has been requested and an investigation will be conducted upon its arrival.
 
Event Description
Consumer sent e-mail stating the toothbrush got really hot and started smoking.Then, the light blew out and the room was filled with the smell of burning plastic.No injury was reported.
 
Manufacturer Narrative
(b)(6) 2021: product investigation results: product return was received and investigated.Investigation results confirmed that the melted area on housing of the handle has been caused by a short circuit overheating the pcb/motor transistor.Our assessment is that while it is not probable that such a malfunction would lead to a serious injury, we cannot foreclose that possibility.Therefore, out of an abundance of caution, we are reporting to the fda.
 
Event Description
Consumer sent e-mail stating the toothbrush got really hot and started smoking.Then, the light blew out and the room was filled with the smell of burning plastic.No injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
BRAUN GMBH WERK MARKTHEIDENFELD
40 baumhofstrasse
marktheidenfeld, D-978 28
GM  D-97828
MDR Report Key11321354
MDR Text Key233048624
Report Number3000302531-2021-00053
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 01/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3765
Device Lot NumberBB606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Initial Date Manufacturer Received 01/16/2021
Initial Date FDA Received02/12/2021
Supplement Dates Manufacturer Received04/20/2021
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-