MAUDE Adverse Event Report: SOMNOMED SOMNODENT FLEX; ORAL APPLIANCE

Model Number	1116212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The import facility was made aware on 01 dec 2022 that the patient experienced an allergic reaction to the device.It was reported that the patient first used the device on the evening of (b)(6) 2022 and woke up the following morning with ulcers on oral surfaces contacting the device, including below the teeth on the gum line, the lips, and the upper palate.The patient experienced minor swelling in her face, lips, and throat, causing difficulty speaking but the patient did not experience any breathing difficulties.The patient went to urgent care for treatment of the allergic reaction.The patient's dental physician instructed the patient to discontinue use of the device immediately.The component that caused the allergic reaction has not been identified at this time.The patient's symptoms have completely resolved as of (b)(6) 2022.The physician has stated intent to return the device to the manufacturer for further investigation.
Additional Manufacturer Narrative
The delay in the report is due to a myriad of enrollment errors with the esg.The test submission was successfully completed on 19 dec 2022, and access to production was not troubleshooted and completed until 28 dec 2022.Submissions through the fdatst were possible, but the account experienced certificate authenticaiton errors in the esg production environment using the certificate generated by the esgportal, delaying the delivery of the report to the emdr database.A third party certificate was obtained on 20 jan 2023 and was uploaded by the esg help desk on 24 jan 2023.Ticket (b)(4) with the esg help desk.

• Brand Name: SOMNODENT FLEX
• Common Device Name: ORAL APPLIANCE
• Manufacturer (Section D): SOMNOMED; 2284 pasong tamo ext. 1231; level 3, allegro center; makati city, national capital region ; RP
• MDR Report Key: 16236688
• Report Number: 3005598536-2022-00001
• Device Sequence Number: 6405888
• Product Code: LRK
• UDI-Device Identifier: 00851826007038
• UDI-Public: (01)00851826007038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/24/2023
• Report Date (Section F): 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1116212
• Device Lot Number: 10019731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/01/2022
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 12/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 01/03/2022