MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS; TOOTHBRUSH, POWERED

Model Number 3765

Device Problems Connection Problem (2900); Separation Problem (4043)

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

Event Type  malfunction  

Manufacturer Narrative

02-aug-2021 update: the reporter informed the company that the product has been discarded.

Event Description

Consumer via phone stated that the oral-b toothbrush head was not staying on while brushing.No injury was reported.

• Brand Name: ORALBPWRRCHGTOOTHBRUSHHANDLE3765GENIUS
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): BRAUN GMBH WERK MARKTHEIDENFELD; 40 baumhofstrasse; marktheidenfeld, D-978 28; GM D-97828
• MDR Report Key: 12301187
• MDR Text Key: 267524382
• Report Number: 3000302531-2021-00270
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3765
• Device Lot Number: BC903191908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/10/2021
• 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