MAUDE Adverse Event Report: SOMNOMED PHILIPPINES INC 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
Related medical device report by importer: (b)(4).The manufacturer 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 investigation is ongoing as the device has not been returned for analysis at this time.Attempts were made by the manufacturer to obtain further information regarding the patient's age, birth, and further information surrounding the event.The delay in this report is due to esg enrollment errors.The test submission was completed on time, but access to the esg production environment was not troubleshooted and completed until after the 30 day deadline.Submissions through the fdatst were possible and successful, but the account experienced errors in the esg production environment, delaying the delivery of the report to the emdr database.Further duplicate and certificate errors delayed the report.

• Brand Name: SOMNODENT FLEX
• Common Device Name: ORAL APPLIANCE
• Manufacturer (Section D): SOMNOMED PHILIPPINES INC; 2284 pasong tamo ext. 1231; level 3, allegro center; makati city, national capital region ; RP
• Manufacturer (Section G): SOMNOMED PHILIPPINES INC; 2284 pasong tamo ext. 1231; level 3, allegro center; makati city, national capital region ; RP
• Manufacturer Contact: sherry panes ; 2284 pasong tamo ext. 1231; level 3, allegro center; makati city, national capital region ; RP
• MDR Report Key: 16433929
• Report Number: 3009440973-2023-00001
• Device Sequence Number: 3198835
• Product Code: LRK
• UDI-Device Identifier: 00851826007038
• UDI-Public: (01)00851826007038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female