MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3769IOSRSG3; TOOTHBRUSH, POWERED - JEQ

Model Number 3769

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Hematemesis (4478)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product return was requested or its in transport.Evaluation will occur upon receipt of product return.

Event Description

Electrical fire in my throat - oral-b electric toothbrush [thermal burn] throwing up blood [haematemesis] my toothbrush literally caught fire and started a small electrical fire in my throat - oral-b [device physical property issue] case narrative: the consumer, unspecified age and gender, reported spontaneously via social media on (b)(6) 2023 that they used oral-b rechargeable toothbrush handle 3769 io series g3 (batch/lot: an23612108) and oral-b power oral care refills, beginning in 2023 (about 6 months ago), and the toothbrush caught fire (2023).They described that the fire started a small electrical fire in their throat that caused them to throw up blood (2023).The consumer went to the emergency room.Treatment details: unknown.Devices used previously: unknown.Relevant history: none reported.Concomitant product(s): none reported.The event and case outcomes were unknown.No further information was provided.12-jan-2024 received follow up via social media: the consumer reported additional treatment details: surgery on throat from the discharge of the toothbrush.The case outcome remained unknown.No further information was provided.Case update from 12-jan-2024: the suspect product, oral-b power oral care refills, was changed to a concomitant product.No further information was provided.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3769IOSRSG3
• 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): UNSPECIFIED MANUFACTURER; unspecified address; unspecified city
• Manufacturer Contact: mgr. affairs, oral care-see co ; mason business center 8700 ma; son-montgomery rd; mason 45040
• MDR Report Key: 18579835
• MDR Text Key: 334733067
• Report Number: 3000302531-2024-00036
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3769
• Device Lot Number: AN23612108
• 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
• Treatment: ORAL-B BRUSHHEADS, VERSION UNKNOWN (NOT APPLICABLE
• Patient Outcome(s): Other