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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REMI BY GRINDGUARD, INC., CUSTOM DENTAL NIGHT GUARD; PROTECTOR, DENTAL
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REMI BY GRINDGUARD, INC., CUSTOM DENTAL NIGHT GUARD; PROTECTOR, DENTAL Back to Search Results
Medical Device Problem Code Product Quality Problem (1506)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Event or Problem Description
I bought this custom dental night guard in (b)(6) because i suffer from tmj.They advertise that the guard is the same as the dentist but the quality wasn't the same as the custom night guard that my dentist prescribed for tmj.The company states that they have the same quality as the dentist but my tmj just got worse.I can't handle the pain now.(b)(6); fda safety report id # (b)(4).
 
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Brand Name
REMI BY GRINDGUARD, INC., CUSTOM DENTAL NIGHT GUARD
Common Device Name
PROTECTOR, DENTAL
MDR Report Key14576295
Report NumberMW5110058
Device Sequence Number15859383
Product Code BRW
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) 05/28/2022
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? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/01/2022
Patient Sequence Number1
Patient SexUnknown
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