MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LOPROFILE 6X20MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number LPLF-106

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Discarded.

Event Description

It was reported that the patient received an eustachian tube dilation procedure.The procedure was successful.30 minutes after the procedure the patient noted significant swelling around face and eyes after attempting a valsalva maneuver in an attempt to clear the ear.The patient was diagnosed with subcutaneous emphysema and was observed for 24 hours.No other reported medical intervention or adverse consequences were reported.

• Brand Name: LOPROFILE 6X20MM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• 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: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13661113
• MDR Text Key: 286525807
• Report Number: 3006345872-2022-00002
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2022

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
• Device Catalogue Number: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/03/2022
• 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