MAUDE Adverse Event Report: RANIR LLC CVS PWTB POLARIS II SO 2PK; TOOTHBRUSH, POWERED

Model Number	PWTB POLARIS II SO 2PK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer purchased a 2 pack of cvs health brand tooth brushes and the bristles were falling out consumer response: i threw away the bristles that it shed ¿ as soon as i started to brush ¿ after i returned home.

• Brand Name: CVS PWTB POLARIS II SO 2PK
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: julia bowen ; 6166988880
• MDR Report Key: 12961161
• Report Number: 1825660-2021-01028
• Device Sequence Number: 17610797
• Product Code: JEQ
• UDI-Device Identifier: 00050428432785
• UDI-Public: 050428432785
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/08/2021

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: PWTB POLARIS II SO 2PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male