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: INTERSECT ENT AA IMPLANT SINUS PROPEL 23MM
  • 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
 

INTERSECT ENT AA IMPLANT SINUS PROPEL 23MM Back to Search Results
Model Number AA70011
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Choking (2464)
Event Date 12/01/2015
Event Type  malfunction  
Event Description
Pt had endoscopy of bilateral sinus by ent physician.He was told that the sinus packing would dissolve.On his way back for his post-op appointment, he was driving on the freeway and one of the packs slid down his throat, obstructing his airway.He had to manually remove it with his fingers.Fortunately there was no harm to the pt.The ent physician was not aware this was a risk, as they were suppose to dissolve.Info re: product: manufacturer: intersect ent exact name of product: propel date used: (b)(6) 2015 procedure preformed: endoscopy of sinuses for nasal polyps/sinusitis right sinus: aa implant sinus propel 23mm aa70011 serial number-n/a lot number: 50828001 catalog: 70011 exp date: 08/28/2017 left sinus: aa implant sinus propel 23mm aa70011 serial number: n/a lot number: 50828001 catalog: 70011 exp date: 08/28/2017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AA IMPLANT SINUS PROPEL 23MM
Type of Device
AA IMPLANT SINUS PROPEL 23MM
Manufacturer (Section D)
INTERSECT ENT
MDR Report Key5454705
MDR Text Key39004526
Report NumberMW5060385
Device Sequence Number1
Product Code OWO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/19/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2017
Device Model NumberAA70011
Device Catalogue Number70011
Device Lot Number50828001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age59 YR
-
-