MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM, FINAL KIT; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number LATSYS24

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

Patient Problem Pain (1994)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Latera implants were placed intranasally in the patient two years ago.The patient presented on (b)(6) 2024 requesting that the implants be removed because they are causing pain.At this time no medical intervention has been taken as a result of the reported event.

Manufacturer Narrative

H3 other text : device remains implanted.

Event Description

Latera implants were placed intranasally in the patient two years ago.The patient presented on (b)(6) 2024 requesting that the implants be removed because they are causing pain.At this time no medical intervention has been taken as a result of the reported event.

Manufacturer Narrative

Correction: f10/h6.

• Brand Name: LATERA 24MM, FINAL KIT
• 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: 18757434
• MDR Text Key: 335991957
• Report Number: 3006345872-2024-00001
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LATSYS24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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