MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM IMPLANT 2; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number LATANI24-I

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

Patient Problem Pain (1994)

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device remains in the patient.

Event Description

The user facility reported that the patient presented several months post-op with pain and tenderness at the cephalic ends of the implants.The patient reported that they needed new glasses.A follow-up appointment has been scheduled.Additional information has been requested from the user facility.

Manufacturer Narrative

Corrected data: b1, b2, b5; h1 and h6.H3 other text : device remains in the patient.

Event Description

The user facility reported that the patient presented several months post-op with pain and tenderness at the cephalic ends of the implants.The patient reported that they needed new glasses.After the follow-up appointment the surgeon did not feel that the symptoms were being caused by the implant ¿ the surgeon offered to administer some steroid injections at the site of pain.The patient refused the steroid injection as treatment and was satisfied with the doctors report.No additional surgery was performed, no additional medical intervention was given as a result of the event.

• Brand Name: LATERA 24MM IMPLANT 2
• 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: 17926255
• MDR Text Key: 325541542
• Report Number: 3006345872-2023-00009
• Device Sequence Number: 1
• Product Code: NHB
• UDI-Device Identifier: 00857037006068
• UDI-Public: 00857037006068
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LATANI24-I
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• 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): Required Intervention