MAUDE Adverse Event Report: RANIR LLC SMARTLY MNTB BULLSEYE SO 2PK; TOOTHBRUSH, MANUAL

Model Number MNTB BULLSEYE SO 2PK WHT

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/29/2020

Event Type  malfunction  

Event Description

Consumer stated: maybe three or four months ago, i used a toothbrush in the pack.I normally use my toothbrushes till its bristles are very frayed.So, i brushed my teeth with this toothbrush when it was at its frayed stage.While "brushing", i felt something sharp in my mouth.I saw that the sharp thing was a very small piece of metal.Its shape is square or rectangle.And because of its shape, its corners are sharp.I wasn't so sure if it came from my toothbrush, but i did wonder why it was in my mouth when i brushed.Now today, i brushed my teeth again with a different toothbrush, not the same one from months ago but the same exact toothbrush.Again, it's at it's frayed stage.Though this time, my brush was too frayed i think, because a chunk of bristles came off when i brushed.I removed the chunk from my mouth, and in this chunk were two to three of the small pieces metal, the same metal from months ago.I now believe the metal from months ago was definitely from this brush.I think it cut into my gums but not too bad.No contact information provided, product not returned.

• Brand Name: SMARTLY MNTB BULLSEYE SO 2PK
• Type of Device: TOOTHBRUSH, MANUAL
• 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 stenske ; 6166988880
• MDR Report Key: 10856612
• MDR Text Key: 218226363
• Report Number: 1825660-2020-00838
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 00071031045834
• UDI-Public: 071031045834
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB BULLSEYE SO 2PK WHT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/20/2020
• Date Manufacturer Received: 10/20/2020
• 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