MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3762; TOOTHBRUSH, POWERED

Model Number 3762

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.We are reporting this case out of an abundance of caution.

Event Description

Sparked.Burnt finger, hand [thermal burn].Sparked - oral-b [device physical property issue].Adult male consumer via phone stated that his oral-b toothbrush sparked while brushing his teeth last week and burnt his finger and hand (beginning (b)(6) 2022).No serious injury was reported.(b)(6) 2022 follow up: the device was an oral-b triumph professional care toothbrush.No serious injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3762
• Type of Device: TOOTHBRUSH, POWERED
• 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: regulatory oral care ; 8700 mason-montgomery rd.; mason, OH 45040
• MDR Report Key: 13513755
• MDR Text Key: 288710026
• Report Number: 3000302531-2022-00052
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3762
• Device Lot Number: R02021012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ORAL-B TOOTHPASTE
• Patient Sex: Male