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

Patient Problem Joint Contracture (4528)

Event Type  Injury  

Event Description

Bought a custom night guard from shopremi - did not fit but wasn't told how to fix.Predatory subscription business model, didn't even get my guard 2 months after order.Guard was the wrong type for my issue.Didn't fit, caused worse tmj problems.My tmj doctor told me they didn't fit it well either causing worse issues.

• Brand Name: SHOPREMI NIGHT GUARD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): REMI; 155 jackson st; apt 1206; san franciso CA 94111
• MDR Report Key: 18094214
• MDR Text Key: 327865791
• Report Number: MW5147916
• 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: Other
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: Asian