MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3709; TOOTHBRUSH, POWERED

Model Number 3709

Device Problem Arcing (2583)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed due to a damaged charger cable.The alleged product malfunction could result in a serious injury with a consumer should such an event occur in the future.Therefore, we are reporting this case out of an abundance of caution.Product return was received.Full evaluation will occur upon investigation completion.15-oct-2021 product investigation results: product return was received and investigated.Product investigation results showed that the complaint is due to mechanical tension to the cord and mains voltage caused electrical arcing from the mains voltage, which is related to user handling.

Event Description

Consumer via e-mail stated that when using their oral-b electric toothbrush, sometimes flames/fireballs came out of the brush itself, both above and below.They no longer dare to use it.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3709
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 12719046
• MDR Text Key: 279021497
• Report Number: 3000302531-2021-00345
• 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: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3709
• Device Lot Number: R341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Date Manufacturer Received: 09/30/2021
• 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