MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9CLEANM9MODELIOM9.1A1.1AD; TOOTHBRUSH, POWERED - JEQ

Model Number IOM9.1A1.1AD

Device Problems Fire (1245); Smoking (1585)

Patient Problems Itching Sensation (1943); Unspecified Eye / Vision Problem (4471)

Event Type  malfunction  

Event Description

Eyes itch [eye pruritus].Eyes burn [eye irritation].Started to smoke - oral-b [device catching fire].Case narrative: male consumer via e-mail stated that his oral-b io9 toothbrush (suspect product lot: ah13640748) started to smoke (approximately 30 minutes after he had left it to charge).His eyes started to itch.No serious injury was reported.On 16-dec-2022 follow up via e-mail: the consumer stated that the oral-b io9 toothbrush made his eyes burn from the smoke.No serious 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: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IO9CLEANM9MODELIOM9.1A1.1AD
• 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: 16111646
• MDR Text Key: 306886155
• Report Number: 3000302531-2023-00007
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IOM9.1A1.1AD
• Device Lot Number: AH13640748
• 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
• Patient Sex: Male