MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3756PROCROSSACTN4000; TOOTHBRUSH, POWERED

Model Number 3756

Device Problems Arcing (2583); Sparking (2595)

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

Event Type  malfunction  

Event Description

Consumer via chatbot stated that the charger for their oral-b pro 4000 crossaction electric rechargeable toothbrush powered braun sparked when connected to power and the wire had a burn mark on it.No injury was reported.

Manufacturer Narrative

This report is being filed due to a damaged charger cable.The alleged product malfunction could result in a serious injury with a consumer should such an event occur in the future.Therefore, we are reporting this case out of an abundance of caution.Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Manufacturer Narrative

17-feb-2022: product investigation results: this report is being filed due to a damaged charger cable.The alleged product malfunction could result in a serious injury with a consumer should such an event occur in the future.Therefore, we are reporting this case out of an abundance of caution.Product return was received and investigated.Product investigation results showed that complaint was caused by an external source.

Event Description

Consumer via chatbot stated that the charger for their oral-b pro 4000 crossaction electric rechargeable toothbrush powered braun sparked when connected to power and the wire had a burn mark on it.No injury was reported.27-jan-2022 case update: the suspect product was oral-b power rechargeable toothbrush handle 3756 pro crossaction 4000.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3756PROCROSSACTN4000
• 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: 13228050
• MDR Text Key: 286434883
• Report Number: 3000302531-2022-00013
• 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,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3756
• Device Lot Number: BF60421934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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