MAUDE Adverse Event Report: RANIR LLC LIFE PWTB POLARIS II; TOOTHBRUSH, POWERED

Model Number PWTB POLARIS II SO W/BRDG

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problems Vomiting (2144); Foreign Body In Patient (2687)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

Customer bought vibratory toothbrush and on her first try, a part of the bristles reportedly dislodged and got stuck in her throat.She had transient difficulty breathing but was able to pull out the bristles with her fingers and made herself throw up to get it out.

• Brand Name: LIFE PWTB POLARIS II
• 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: rebekah hamilton ; 6166988880
• MDR Report Key: 10983349
• MDR Text Key: 221298727
• Report Number: 1825660-2020-00860
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 5780090834
• UDI-Public: 5780090834
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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 SO W/BRDG
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/11/2020
• Date Manufacturer Received: 11/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1