MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM, FINAL KIT; LATERA ABSORBABLE NASAL

Model Number	LATSYS24
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a year after the patient had latera implants placed the patient was experiencing discomfort when wearing glasses and stated the device did not work as intended.The patient had an additional procedure to remove the implants, although they had dissolved and were not able to be removed.No additional adverse consequences were reported.
Additional Manufacturer Narrative
Device remains in the patient.
Additional Manufacturer Narrative
Corrected data: f10.
Event or Problem Description
It was reported that a year after the patient had latera implants placed the patient was experiencing discomfort when wearing glasses and stated the device did not work as intended.The patient had an additional procedure to remove the implants, although they had dissolved and were not able to be removed.No additional adverse consequences were reported.

• Brand Name: LATERA 24MM, FINAL KIT
• Common Device Name: LATERA ABSORBABLE NASAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16648804
• Report Number: 3006345872-2023-00006
• Device Sequence Number: 5516775
• Product Code: NHB
• UDI-Device Identifier: 00857037006075
• UDI-Public: 00857037006075
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: Health Professional
• Device Model Number: LATSYS24
• Device Catalogue Number: LATSYS24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Female