MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS8000MODELD701.515.5XC; TOOTHBRUSH, POWERED - JEQ

Model Number D701.515.5XC

Device Problems Fire (1245); Sparking (2595); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Charging in kitchen, there was loud sound suddenly with a spark and the cable burned, power drop - oral-b, device catching fire.Charging in the kitchen, there was a loud sound suddenly with a spark and the cable burned, power drop - oral-b, device physical property issue.Case narrative: consumer via phone stated that while charging their oral-b electric toothbrush in the kitchen, there was suddenly a loud sound with a spark and the cable burned.No injury was reported.

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS8000MODELD701.515.5XC
• 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: 14469105
• MDR Text Key: 293849794
• Report Number: 3000302531-2022-00202
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D701.515.5XC
• 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