MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM, FINAL KIT; NHB, LATERA ABSORBABLE NASAL

Catalog Number LATSYS24

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

Patient Problems Bruise/Contusion (1754); Deformity/ Disfigurement (2360)

Event Date 04/01/2022

Event Type  Injury  

Event Description

The patient reported that they had latera implants implanted in 2019 that have not dissolved.The patient reported experiencing discoloration of the skin, bruising and disfigurement of the nose.The patient requested the latera implants be removed and that procedure was completed in (b)(6) 2022.Additional information is not available at this time.

Manufacturer Narrative

Device not available.

Event Description

The patient reported that they had latera implants implanted in 2019 that have not dissolved.The patient reported experiencing discoloration of the skin, bruising and disfigurement of the nose.The patient requested the latera implants be removed and that procedure was completed on (b)(6) 2022.Additional information is not available at this time.

Manufacturer Narrative

Additional information received.

• Brand Name: LATERA 24MM, FINAL KIT
• Type of Device: NHB, LATERA ABSORBABLE NASAL
• 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; suite 40; portage, MI 49002 ; 2693237700
• MDR Report Key: 14240809
• MDR Text Key: 290445730
• Report Number: 3006345872-2022-00003
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LATSYS24
• Device Lot Number: A211164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• 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