MAUDE Adverse Event Report: SIESTA MEDICAL, INC. ENCORE SYSTEM; INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA

Model Number	FG0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated with the encore system and about 2 weeks later presented with neck swelling and an infection at the lower incision.The incision was drained and packed to treat the infection and the patient was treated with augmentin.The symptoms worsened, the physician opened and drained the incision and continued the patient on augmentin.As of the date of this report, drainage has improved.
Event or Problem Description
The patient was treated with the encore system and about 2 weeks later presented with neck swelling and an infection at the lower incision.The incision was drained and packed to treat the infection and the patient was treated with augmentin.The symptoms worsened, the physician opened and drained the incision and continued the patient on augmentin.About 1 month later, the drainage has improved.The physician decided to explant the device due to persistent drainage.Nothing of note was observed during the explant or exploration.

• Brand Name: ENCORE SYSTEM
• Common Device Name: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEA
• Manufacturer (Section D): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer (Section G): SIESTA MEDICAL, INC.; 101 church street; suite 3; los gatos CA 95030
• Manufacturer Contact: michael kolber ; 101 church street; suite 3; los gatos, CA 95030 ; 4083209424
• MDR Report Key: 18697495
• Report Number: 3008792120-2024-00004
• Device Sequence Number: 8424137
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)250930(10)1058
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K213159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: FG0002
• Device Lot Number: 1058
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REVOLUTION LOT NUMBER 1016.; REVOLUTION LOT NUMBER 1016.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female