MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9MODELIOM9.1A1.5ADH; TOOTHBRUSH, POWERED - JEQ

Model Number IOM9.1A1.5ADH

Device Problems Crack (1135); Fire (1245); Device Emits Odor (1425); Smoking (1585)

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

Event Type  malfunction  

Event Description

Bedroom smelling like strong chemical.Origin of the smell and the smoke, it turns out that it came from the brush that was cracked at its base - oral-b [device catching fire] bedroom smelling like strong chemical.Came from the brush that was cracked at its base - oral-b [device issue].Case narrative: consumer via e-mail stated that last week, they came home from work to find their bedroom smelling like a super strong chemical.They determined that the origin of the smell and the smoke was the oral-b toothbrush that was cracked at its base.No injury was reported.

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.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9SRSM9MODELIOM9.1A1.5ADH
• 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: 15140488
• MDR Text Key: 297007049
• Report Number: 3000302531-2022-00291
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IOM9.1A1.5ADH
• Device Lot Number: AH04220537
• Was Device Available for Evaluation?: No
• 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