MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBRCHGTOOTHBRUSHHANDLE3756; TOOTHBRUSH, POWERED - JEQ

Model Number 3756

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Manufacturer Narrative

Complained product will not be not available.

Event Description

First degree burns - skin - oral-b [burns first degree] stinging skin - right hand palm [pain of skin] blew up - oral-b toothbrush [device expulsion] letting out smoke - oral-b toothbrush [device catching fire] overheated - oral-b toothbrush [device temperature issue] case narrative: parent via chat reported that their son's oral-b toothbrush handle, type 3756 blew up while he was using it and caused first degree burns.No serious injury was reported.25-feb-2024 via digital safety assessment survey: reporter's son was 9 years old and required an urgent care/hospital clinic visit.He experienced stinging skin on his right hand palm.No serious injury was reported.27-feb-2024 via e-mail and picture: the suspect product lot was 2 af 810 10139.Parent reported that the oral-b toothbrush handle, type 3756 overheated and was letting out smoke.No serious injury was reported.

• Brand Name: ORALBRCHGTOOTHBRUSHHANDLE3756
• 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: 18980154
• MDR Text Key: 338620494
• Report Number: 3000302531-2024-00150
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: 2 AF 810 10139
• 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 Age: 9 YR
• Patient Sex: Male