MAUDE Adverse Event Report: RANIR LLC UP&UP PWTB POLARIS II BLK; TOOTHBRUSH, POWERED

Model Number	PWTB POLARIS II BLK SO 2PK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated: i purchased the (b)(4) instead of (b)(4) toothbrush for the first time and was highly disappointed.After using the brush for 3 days the plastic pieces in between the bristles started to break off, while i was brushing my teeth.No consumer contact info provided, product not returned.

• Brand Name: UP&UP PWTB POLARIS II BLK
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10856538
• Report Number: 1825660-2020-00837
• Device Sequence Number: 11570284
• Product Code: JEQ
• UDI-Device Identifier: 00071031846523
• UDI-Public: 071031846523
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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 BLK SO 2PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1