MAUDE Adverse Event Report: UNKNOWN ORTHOTIC APPLIANCE FOR TMJ PM; MOUTHGUARD, PRESCRIPTION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/20/2022

Event Type  Injury  

Event Description

I was prescribed a mouth appliance to help with tmj pain.My dentist made a mold of my teeth and created a hard device that fits over my bottom teeth to be worn at night.I first received the appliance around (b)(6) 2022.I returned twice because it was hurting a tooth but was told to keep wearing it.On (b)(6) i woke up with severe jaw pain and could not fully close my mouth.They did another adjustment of the device and suggested i wait a few days before trying it again.When i wore it one night, on (b)(6), i woke in the morning with pain so severe that i couldn't eat anything but soft food for days.It is (b)(6) now and i am still in more pain than i was before the device.I'd say in total i wore the device only 5-10 times and it still caused me this much pain.Name of the company that makes the medical device: the facial pain center.Fda safety report id #(b)(4).

• Brand Name: ORTHOTIC APPLIANCE FOR TMJ PM
• Type of Device: MOUTHGUARD, PRESCRIPTION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15233818
• MDR Text Key: 298085783
• Report Number: MW5111493
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• 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
• Patient Sequence Number: 1
• Treatment: ADVIL, FEXOFENADINE; LAMICTAL, VENTOLIN, MONTELUKAST, ZOLPIDEM, QUETIAPINE, RIZATRIPTAN, XANAX
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White