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

Lot Number NOT AVAILABLE

Device Problem Arcing (2583)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

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.

Event Description

Toothbrush plug shocked me [electric shock].Toothbrush charger cord ripped exposing the wire, burn mark on the prongs [device physical property issue].Case description: consumer contacted via e-mail and stated that when plugging in the toothbrush charger, the plug shocked him/her; the cord ripped exposing the wire, and there was a burn mark on the metal prongs.No serious injury was reported.

• 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: 11125556
• MDR Text Key: 227755928
• Report Number: 3000302531-2021-00005
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: 12/11/2020
• 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