MAUDE Adverse Event Report: RANIR LLC CVS EASY FLEX RBH; TOOTHBRUSH, POWERED

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated that they were unhappy with the item purchased/cvs health easy flex total power(electronic toothbrush)/every time the customer brushed their teeth, one or two bristles would fall off in their mouth/customer.2 brush heads out of the 3pk had bristles falling out.

• Brand Name: CVS EASY FLEX RBH
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 11801037
• Report Number: 1825660-2021-00945
• Device Sequence Number: 3559719
• Product Code: JEQ
• UDI-Device Identifier: 00050428279717
• UDI-Public: 050428279717
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/10/2021

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1