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

Model Number FG0002

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

Patient Problem Skin Infection (4544)

Event Date 12/04/2023

Event Type  Injury  

Event Description

The patient was implanted with an encore system.He experienced an infection, for which he received antibiotic therapy and surgical excesion of granulation tissue.

• Brand Name: ENCORE SYSTEM
• Type of Device: INTRAORAL DEVICE FOR SNORING AND OBSTRUCTIVE SLEEP APNEEA
• 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: 18625645
• MDR Text Key: 334345780
• Report Number: 3008792120-2024-00002
• Device Sequence Number: 1
• Product Code: ORY
• UDI-Device Identifier: 00862211000206
• UDI-Public: (01)00862211000206(17)250630(10)1039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG0002
• Device Lot Number: 1039
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLINDAMYCIN; DOXYCYCLINE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male