MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS LOPROFILE MULTISINUS DILATION SYSTEM; DILATOR, NASAL

Model Number MSB&LLF

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

When inserting dilation system, the light did not go on.

• Brand Name: XPRESS LOPROFILE MULTISINUS DILATION SYSTEM
• Type of Device: DILATOR, NASAL
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly lane n suite 40; plymouth MN 55447
• MDR Report Key: 4322344
• MDR Text Key: 5131857
• Report Number: 4322344
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSB&LLF
• Device Catalogue Number: LPLF-106
• Device Lot Number: A5472
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR