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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REMI NIGHT GUARD; MOUTHGUARD, OVER-THE-COUNTER
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REMI NIGHT GUARD; MOUTHGUARD, OVER-THE-COUNTER Back to Search Results
Medical Device Problem Codes Product Quality Problem (1506); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event 09/15/2022
Type of Reportable Event Serious Injury
Event or Problem Description
I purchased a night guard online and after i got it in the mail and wore it, i woke up the next day with my teeth feeling like they were moved and were hurting.I wore it again the next night but i can tell it was moving my teeth and my gums were bleeding.I knew this was not right so i contacted my dentist who was able to see me right away and look at my guard from remi.She told me that it was definitely causing an alignment issue.It was causing a malocclusion and suggested a different solution other than this company.She said the quality of this product was not good and now i have to pay for an expensive treatment.Stay away from this company because they do not answer customer service requests and now i have to pay a ton of money for what? fda safety report id# (b)(4).
 
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Brand Name
NIGHT GUARD
Common Device Name
MOUTHGUARD, OVER-THE-COUNTER
Manufacturer (Section D)
REMI
MDR Report Key15543380
Report NumberMW5112425
Device Sequence Number5362192
Product Code OBR
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 09/30/2022
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
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/04/2022
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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