MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B DUALACTION BRUSHHEADS; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer via phone stated that their oral-b dual brush heads on the bottom stayed in their mouth.No injury was reported.

• Brand Name: ORAL-B DUALACTION BRUSHHEADS
• 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: 12860693
• MDR Text Key: 282331514
• Report Number: 3000302531-2021-00376
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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: 11/02/2021
• 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