MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 14; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 14

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/22/2019

Event Type  malfunction  

Event Description

Consumer stated "i loved these mouth guards.I thought they fit great and they didn't make me gag in my sleep.They are priced great when compared to other options.At one point i started noticing a dental issue, so i went to the dentist.Turns out my teeth were moving around due to this and i was catching food in a new gap.The dentist confirmed because the bite area only has contact in the small area you bite down on, you may make teeth in those areas move because the bite area is focusing on specific spots in your mouth.The dentist suggested i try a $(b)(6) mouth guard that sits on the front teeth only instead (because your body knows not to bite down at all times on those.) turns out i am a machine, i made my front teeth move over a few months as well." no contact information provided, product was not returned for review.Product labeling indicates not to use for more than 3 months from initial use without checking in with your dentist.Unclear how long this consumer used the guard.

• Brand Name: PLACKERS MTH GD GNM 14
• 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 ; 6166988880
• MDR Report Key: 9153492
• MDR Text Key: 167641545
• Report Number: 1825660-2019-00629
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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 14
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/06/2019
• Date Manufacturer Received: 09/06/2019
• 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