MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 10CT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 02/08/2019

Event Type  Injury  

Event Description

Consumer stated she had been a long time consumer of your grind no more night guards.She enjoyed using the guard as it's so much smaller and lighter than the big, full-coverage night guard.Consumer stated "it wasn't until recently that i learned i now have a malocclusion as a result of long-time use of grind no more.My back teeth no longer touch at exactly where the bite plates touch the teeth, thereby causing my front teeth to wear away and cause continuous chipping of that front-tooth bonding i have.At the suggestion of my dentist, i had an orthodontic consultation and 12-18 months worth of treatment to fix my problem.I'm sad that i wasn't aware that long-term use of your product would cause such major issues.She used the guards for 5 years (it was not clear if she was using the same exact guard, but it's believed that she was using several guards over the 5 years).Directions state not to use the product more than 3 months from initial use without consulting your dentist and to continue seeing your dentist every six months thereafter while using the product.

• Brand Name: PLACKERS MTH GD GNM
• 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: 8386369
• MDR Text Key: 137718516
• Report Number: 1825660-2019-00517
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094020
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 10CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/08/2019
• Date Manufacturer Received: 02/08/2019
• 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