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: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
  • 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
 

TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 15140
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "the facility reports that smooth air deflation through the red plug was unattainable at the initial clinical use." issue reported occurred during functional testing prior to a patient use.Patient condition reported as fine.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and there was no damage observed.The device was inflated and deflated with the check valve normally.It was observed that the deflation was slightly sluggish when deflated with the red plug open; however, with a slight pinch on the sides of the red plug the deflation improved.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, it was found that the device was fully functional, and could be inflated and deflated with the check valve normally.The deflation could be improved with a slight pinch on the sides of the red plug.This could be due to inevitable expansion and contraction of the components material during logistics movement over time.Trending of this incident will be closely monitored.
 
Event Description
Customer complaint alleges "the facility reports that smooth air deflation through the red plug was unattainable at the initial clinical use." issue reported occurred during functional testing prior to a patient use.Patient condition reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LMA PROSEAL, REU, SIZE 4 (150040)
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8024362
MDR Text Key125757744
Report Number9681900-2018-00037
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 10/29/2018
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 No Information
Device Catalogue Number15140
Device Lot NumberSN:8VTAAQD3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2018
Initial Date Manufacturer Received 10/29/2018
Initial Date FDA Received10/31/2018
Supplement Dates Manufacturer Received12/07/2018
Supplement Dates FDA Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
-
-