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

Model Number PWTB POLARIS II BLK SO 2PK

Device Problems Product Quality Problem (1506); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

Customer stated : purchased equate vibraclean pulsating soft power toothbrush and the toothbrush after two uses the bristles began falling out.

• Brand Name: EQUATE PWTB POLARIS II BLK SO 2PK
• Type of Device: 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: 12928377
• MDR Text Key: 283244744
• Report Number: 1825660-2021-01027
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 68113107074
• UDI-Public: 68113107074
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PWTB POLARIS II BLK SO 2PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/06/2021
• Date Manufacturer Received: 11/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1