MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRS; TOOTHBRUSH, POWERED - JEQ

Model Number IOM9.1A1.1AD

Device Problems Fire (1245); Device Emits Odor (1425)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed due to an alleged fire event.This report is being filled out of an abundance of caution.The reporter informed the company that the product has been discarded.

Event Description

Toxic smoke coming from the toothbrush - oral-b [device catching fire].Case narrative: consumer via e-mail stated that they came home noticing that the smell was quite unusual.They went to the bathroom, as the smell seemed to come from there, and found the room with a toxic smoke coming from the oral-b io9 toothbrush.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRS
• Type of Device: TOOTHBRUSH, POWERED - JEQ
• 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: mgr. affairs, oral care-see co ; mason business center 8700; mason-montgomery rd; mason 45040
• MDR Report Key: 15913856
• MDR Text Key: 304784459
• Report Number: 3000302531-2022-00432
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• 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: 12/05/2022

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: IOM9.1A1.1AD
• Device Lot Number: AH02410021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2022
• 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: Unknown
• Patient Sequence Number: 1