MAUDE Adverse Event Report: REMI REMI; MOUTHGUARD, OVER-THE-COUNTER

Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
This is the third time you have sent me a new mouth guard that just doesn't fit.The one you just sent me is way too thick in the molars and would create a tmj problem.I'm really concerned about your quality control.I can see this happening once but not 3 times.Reference report #mw5115307, #mw5115308.

• Brand Name: REMI
• Common Device Name: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): REMI; 3150 polk st, ste c103 d; san francisco CA 94109
• MDR Report Key: 16459633
• Report Number: MW5115309
• Device Sequence Number: 3134429
• Product Code: OBR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown