MAUDE Adverse Event Report: SAINSBURY EF II BULK TRAY GRN; TOOTHBRUSH, POWERED

Model Number	EF II BULK TRAY GRN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ran2021/559 bristles coming out.

• Brand Name: SAINSBURY EF II BULK TRAY GRN
• Common Device Name: TOOTHBRUSH, POWERED
• MDR Report Key: 12333309
• Report Number: 1825660-2021-00993
• Device Sequence Number: 19808685
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: EF II BULK TRAY GRN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1