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

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event 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 #mw5115308, #mw5115309.

• Brand Name: REMI
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): REMI; 3150 polk st; ste c103 d; san francisco CA 94109
• MDR Report Key: 16459603
• MDR Text Key: 310536647
• Report Number: MW5115307
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other