MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3709; TOOTHBRUSH, POWERED

Model Number 3709

Device Problem Arcing (2583)

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

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

Consumer via e-mail stated that while their (b)(6) year old son was brushing his teeth, the charger cable of one of their oral-b toothbrushes exploded.It flashed and then the fuses came out.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3709
• 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: 13051273
• MDR Text Key: 282956245
• Report Number: 3000302531-2021-00409
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3709
• Device Lot Number: R84352203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2021
• 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 Age: 8 YR
• Patient Sex: Male