MAUDE Adverse Event Report: DENTEK ORAL CARE INC. PROFESSIONAL-FIT DENTAL GUARD; MOUTHGUARD, OVER-THE-COUNTER

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Temporo-mandibular joint derangement resulted from dental guard use under supervision of dental professional.Fda safety report id# (b)(4).

• Brand Name: PROFESSIONAL-FIT DENTAL GUARD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): DENTEK ORAL CARE INC.
• MDR Report Key: 15210176
• MDR Text Key: 297786806
• Report Number: MW5111417
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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): Disability