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

Catalog Number UNK_INE

Device Problems Fracture (1260); Expulsion (2933)

Patient Problems Pain (1994); Skin Discoloration (2074)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : remains implanted in the patient.

Event 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
• Type of Device: 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
• MDR Text Key: 336283336
• Report Number: 3006345872-2024-00003
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other