MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756PRO1500; TOOTHBRUSH, POWERED

Model Number 3756

Device Problems Melted (1385); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Consumer via phone stated that they found a burn hole forming on the oral-b toothbrush that they think was from the battery.It was located on the charging light.No injury was reported.

Manufacturer Narrative

This report is being filed due to a melted hole in the handle.It has been determined that a melted area on housing of the handle could have 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.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756PRO1500
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer (Section G): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• Manufacturer Contact: regulatory oral care ; 8700 mason-montgomery rd.; mason, OH 45040
• MDR Report Key: 13869115
• MDR Text Key: 294027768
• Report Number: 3000302531-2022-00096
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: 2AF70531053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1