MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3758IOSRSM10; TOOTHBRUSH, POWERED - JEQ

Model Number 3758

Device Problems Leak/Splash (1354); Explosion (4006)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Small cut on chin - skin [skin laceration].Toothbrush explodes - oral-b [device battery explosion].Fluid leaking from the inside of the toothbrush - oral-b [device leakage].Case narrative: a consumer via e-mail stated that they had a problem with their oral-b i10 toothbrush.No injury was reported.21-nov-2022 follow-up via e-mail: a parent stated that the oral-b io m10 toothbrush exploded and their son got a small cut on his chin.There was also fluid leaking from inside of the toothbrush.No serious injury was reported.22-nov-2022 follow-up via e-mail: they took their son to a medical center and he was improved.They used oral-b 123 toothpaste.No serious injury was reported.24-nov-2022 follow-up via phone: the patient was recovered.No serious injury was reported.30-nov-2022 follow-up via e-mail: the patient was 14 years old.No serious injury was reported.

Manufacturer Narrative

The reporter informed the company that the product has been discarded.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3758IOSRSM10
• 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: 15994785
• MDR Text Key: 305590494
• Report Number: 3000302531-2022-00442
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: PO
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3758
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: ORAL-B 123 TOOTHPASTE
• Patient Age: 14 YR
• Patient Sex: Male