MAUDE Adverse Event Report: UNKNOWN ORAL SLEEP APNEA APPLIANCE; DEVICE, ANTI-SNORING

Device Problem Use of Device Problem (1670)

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

Event Date 03/31/2020

Event Type  Injury  

Event Description

New dentist/application process and trial of oral sleep apnea appliance, which caused loosened tooth still existing today.Not sure - dental lab.

• Brand Name: ORAL SLEEP APNEA APPLIANCE
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16684190
• MDR Text Key: 312935582
• Report Number: MW5116369
• Device Sequence Number: 1
• Product Code: LRK
• 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: 04/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: APAP, BLOOD SUGAR MONITOR, METFORMIN, LOSARTAN, GUANFACINE, EFFEXOR XR, SEROQUEL, CYCLOBENZAPRINE, VYVANSE, ALBUTEROL INHALER.; ORAL BRUXISM NIGHT GUARD, GLUCOSAMINE/CHONDROINTON SUPPLEMENT, VITAMIN C SUPPLEMENT GUMMIES, HAIR/SKIN/NAILS SUPPLEMENT GUMMIES.
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White