MAUDE Adverse Event Report: ORAL-B BRUSHHEADS, VERSION UNKNOWN; TOOTHBRUSH, POWERED

Lot Number NOT AVAILABLE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Stabbed - mouth [mouth injury].Toothbrush head come loose and falls off, while brushing head has detached [device breakage].Consumer sent e-mail reporting that the toothbrush head comes loose and falls off on its own or when brushing.The head had detached while brushing.No serious injury was reported.

Manufacturer Narrative

13-aug-2021 concomitant product investigation results: product return was received and investigated.Product investigation results showed that the complaint is caused by wear of the driving shaft due to usage of abrasive toothpaste in combination with insufficient cleaning with use over many years.

Event Description

Stabbed - mouth [mouth injury].Toothbrush head come loose and falls off, while brushing head has detached [device breakage].Consumer sent e-mail reporting that the toothbrush head comes loose and falls off on its own or when brushing.The head had detached while brushing.No serious injury was reported.

• Brand Name: ORAL-B BRUSHHEADS, VERSION UNKNOWN
• Type of Device: TOOTHBRUSH, POWERED
• MDR Report Key: 9529794
• MDR Text Key: 191198000
• Report Number: 3000302531-2019-00234
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 08/20/2021
• 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 SMART SERIES 6500 ELECTRIC RECHARGEABLE TB.; ORALBPWRRCHGTOOTHBRUSHHANDLE3764.