MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO8SRSM8; TOOTHBRUSH, POWERED - JEQ

Model Number 3758

Device Problems Fire (1245); Fluid/Blood Leak (1250); Device Emits Odor (1425); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

Event Description

Smoke coming out of it - oral-b [device catching fire].Clear liquid coming out of bottom of toothbrush.Very kind of thick and doesn't smell good liquid - oral-b [device leakage].Case narrative: male consumer via phone stated that clear, thick liquid that did not smell good came out of the bottom of the oral-b io8 toothbrush, and when he turned it on, there was smoke coming out of it.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO8SRSM8
• 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: 15239228
• MDR Text Key: 298028876
• Report Number: 3000302531-2022-00314
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 08/17/2022

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: 3758
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male