MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. UNKNOWN_ENTELLUS_PRODUCT; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number	UNK_INE
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : remains implanted in the patient.
Event or Problem Description
The patient reported that on (b)(6) 2022, they underwent a vision septoplasty, bilateral nasal valve reconstruction and a latera implantation.Four months post-op the patient reported facial discomfort, headaches and migraines.A brown spot presented on the nose which was painful.The spot turned into an inflectional spot and on (b)(6), 2023 a small piece of the implant came through the skin in the brown spot that had formed.No additional information is available from the initial reporter.

• Brand Name: UNKNOWN_ENTELLUS_PRODUCT
• Common Device Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• 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: 18781843
• Report Number: 3006345872-2024-00003
• Device Sequence Number: 19905776
• Product Code: NHB
• UDI-Device Identifier: 00857037006068
• UDI-Public: 00857037006068
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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 Catalogue Number: UNK_INE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/26/2024
• 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: Other
• Patient Sex: Unknown