MAUDE Adverse Event Report: BRAUN GMBH WERK MARKTHEIDENFELD ORAL-B FLOSS ACTION BRUSH HEAD; TOOTHBRUSH, POWERED

Lot Number 9117331

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

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

Event Type  malfunction  

Manufacturer Narrative

Product return was requested but not received so far.Full evaluation will occur upon receipt of returned product.

Event Description

Consumer via phone stated that when they were using the oral-b floss action brush head, the metal piece that was inside of the brush head came out and fell in their mouth.The brush head does not sit on the handle and it does not rotate any more.No injury was reported.

Manufacturer Narrative

22-dec-2021 product investigation results: product return was received and identified as a non-genuine oral-b product, it was not manufactured under p&g control.

Event Description

Consumer via phone stated that when they were using the oral-b floss action brush head, the metal piece that was inside of the brush head came out and fell in their mouth.The brush head does not sit on the handle and it does not rotate any more.No injury was reported.

• Brand Name: ORAL-B FLOSS ACTION BRUSH HEAD
• 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: 12360819
• MDR Text Key: 274442728
• Report Number: 3000302531-2021-00285
• 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,Followup
• Report Date: 08/06/2021

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 Lot Number: 9117331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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.; ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN.