MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765; TOOTHBRUSH, POWERED

Model Number 3765

Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

31-aug-2021: 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

Electric toothbrush started burning.It started smoking and smelled burnt, then there were flames [device catching fire].Melted area on housing of the handle caused by a short circuit overheating the pcb/motor transistor [manufacturing issue].Case description: consumer via e-mail stated that the oral-b power rechargeable toothbrush handle started burning.It started smoking and smelled burnt, then there were flames.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 12539552
• MDR Text Key: 274442501
• Report Number: 3000302531-2021-00316
• 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
• Report Date: 06/23/2021

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: BB605020813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1