MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT; TOOTHBRUSH, POWERED

Model Number EB417

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Type  malfunction  

Event Description

Consumer via phone stated that their oral-b dual action brush head fell off into their mouth.No injury was reported.18-oct-2021 follow up via phone: the consumer was a male.No injury was reported.

Manufacturer Narrative

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

• Brand Name: ORALBPWRPWRORALCARERFLSDUALACTNEB417BRUSHSET3CT
• 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: 12771515
• MDR Text Key: 281288403
• Report Number: 3000302531-2021-00360
• 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: 10/15/2021

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: EB417
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/08/2021
• 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
• Treatment: ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN
• Patient Sex: Male