MAUDE Adverse Event Report: RANIR LLC UP&UP MNTB KDS SO 4PK; TOOTHBRUSH, MANUAL

Model Number MNTB KDS SO 4PK

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

Consumer stated: these toothbrushes are great, unless you have a toddler like mine who incessantly chews on everything.There is a soft rubber/silicon inlay on the handle and head of the toothbrush, and the temptation is too great for my son.Lol.I am constantly having to remove debris from his mouth and take the toothbrush away, which turns into a battle.For non-chewers, though, i can see this being a great product, which is why i only knocked off one star.

• Brand Name: UP&UP MNTB KDS SO 4PK
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI
• MDR Report Key: 11850586
• MDR Text Key: 258685602
• Report Number: 1825660-2021-00954
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 71031266529
• UDI-Public: 71031266529
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB KDS SO 4PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/20/2021
• Date Manufacturer Received: 04/20/2021
• 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