MAUDE Adverse Event Report: DENTEK ORAL CARE, INC. DENTEK ULTIMATE DENTAL GUARD FOR NIGHTTIME TEETH GRINDING; MOUTHGUARD, OVER-THE-COUNTER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 10/19/2021

Event Type  Injury  

Event Description

I purchased a dentek ultimate dental guard under advising of my dentist to purchase an over the counter mouth guard to protect against bruxism in (b)(6) 2020.I molded it until i had an adequate fit and proceeded as normal.My dentist approved the night guard.Over time i noticed my bite changing and i was not able to bite foods like pizza.I saw my dentist in (b)(6) 2021 and they did not identify any issues.At my most recent visit in (b)(6) 2021, my new dentist was alarmed by my bite and referred me to an orthodontist.The orthodontist diagnosed me with a severe malocclusion and that i would need braces and other orthodontia to restore my bite.Fda safety report id # (b)(4).

• Brand Name: DENTEK ULTIMATE DENTAL GUARD FOR NIGHTTIME TEETH GRINDING
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): DENTEK ORAL CARE, INC.
• MDR Report Key: 12681996
• MDR Text Key: 278195510
• Report Number: MW5104869
• Device Sequence Number: 1
• Product Code: OBR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 54