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

Model Number 3758

Device Problems Failure to Charge (1085); Fire (1245); Smoking (1585)

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

Event Type  malfunction  

Event Description

Started to give off some kind of smoke - oral-b [device catching fire].Doesn¿t charge or respond to anything - oral-b [device physical property issue].Case narrative: consumer via e-mail stated that their oral-b io 9 toothbrush gave off some kind of smoke and stopped working.It didn¿t charge or respond to anything.The suspect product lot was 1301b211m0.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: 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: 14731294
• MDR Text Key: 294850889
• Report Number: 3000302531-2022-00242
• 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: 06/17/2022

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
• Device Lot Number: 1301B211M0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2022
• 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: Reuse
• Patient Sequence Number: 1