Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LOPROFILE 6X20MM; INSTRUMENT, ENT MANUAL SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENTELLUS MEDICAL, INC. LOPROFILE 6X20MM; INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results
Model Number MSB&LLF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 08/22/2020
Event Type  Injury  
Manufacturer Narrative
Device discarded by user facility.
 
Event Description
It was reported that a patient experienced a csf leak immediately following a multi-sinus balloon dilation procedure.The patient had surgery to patch the csf leak, was hospitalized for 2-3 days and then discharged.No further patient injury or complications have been reported.
 
Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that a patient experienced a csf leak immediately following a multi-sinus balloon dilation procedure.The patient had surgery to patch the csf leak, was hospitalized for 2-3 days and then discharged.No further patient injury or complications have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key10541645
MDR Text Key207176979
Report Number3006345872-2020-00006
Device Sequence Number1
Product Code LRC
UDI-Device Identifier00857326005017
UDI-Public00857326005017
Combination Product (y/n)N
PMA/PMN Number
K163509
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/04/2020
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 Operator Health Professional
Device Model NumberMSB&LLF
Device Catalogue NumberLPLF-106
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/22/2020
Initial Date FDA Received09/16/2020
Supplement Dates Manufacturer Received11/29/2020
Supplement Dates FDA Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-