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

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.

• 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 Key: 11321354
• MDR Text Key: 233048624
• Report Number: 3000302531-2021-00053
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 3765
• Device Lot Number: BB606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: 01/16/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1