MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problems Device Emits Odor (1425); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Consumer via e-mail stated that yesterday evening they had a power outage and the electrical meter indicated a problem in the bathroom.When they entered the bathroom, there was a burning smell and they found the electrical wire of the burned oral-b toothbrush and it was cut in two.They can no longer recharge their son's oral-b toothbrush.No injury was reported.13-jan-2022 follow up via phone: the consumer confirmed that the oral-b toothbrush charger's wire burned and cut in two (not the actual toothbrush).No injury was reported.14-jan-2022 follow up via e-mail: the consumer stated that they had issues with an oral-b vitality toothbrush.No injury was reported.

Manufacturer Narrative

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

• Brand Name: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• 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: 13505597
• MDR Text Key: 288098752
• Report Number: 3000302531-2022-00036
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• 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
• Patient Sex: Male