MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA ABSORBABLE NASAL; EAR, NOSE, THROAT SYNTHETIC POLYMER MATERIAL

Model Number	LATANI24
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant dissolves.
Event or Problem Description
The patient developed a cyst in their left nasal sidewall.The latera was implanted 1.5 years ago.Eventually the physician took the patient into surgery for external removal.The patient had good results regarding their airway, and cosmetically, it healed well.

• Brand Name: LATERA ABSORBABLE NASAL
• Common Device Name: EAR, NOSE, THROAT SYNTHETIC POLYMER MATERIAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• MDR Report Key: 10525525
• Report Number: 3006345872-2020-00005
• Device Sequence Number: 2679746
• Product Code: NHB
• UDI-Device Identifier: 00857037006082
• UDI-Public: 00857037006082
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: LATANI24
• Device Catalogue Number: LATANI24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/11/2020
• 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