MAUDE Adverse Event Report: RANIR LLC PLACKERS STOP GRINDING 1CT; MOUTHGUARD, OVER-THE-COUNTER

Model Number STOP GRINDING 1CT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Sensitivity of Teeth (2427)

Event Date 05/07/2019

Event Type  Injury  

Event Description

Consumer has been using the stop grinding guard for a number of years.Her teeth now don't touch, it's been like this for a year.She went to the dentist recently because she was trying to find a way to fix the problem.They sent her to the orthodontist.They asked her what her routine was and they said it was because of the guard she was using.They said the only way to fix it is to grind her teeth until they touch or she needs to get braces.She is asking for us to pay for braces.Labeling on the product indicates not to use the guard for more than 3 months from initial use without consulting your dentist.Consumer indicated that she was going to the dentist regularly but didn't state that she consulted with the dentist about the guard.

• Brand Name: PLACKERS STOP GRINDING 1CT
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8647276
• MDR Text Key: 146277258
• Report Number: 1825660-2019-00566
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K09420
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STOP GRINDING 1CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/07/2019
• Date Manufacturer Received: 05/07/2019
• 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