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 CLASSIC SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE
  • 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 CLASSIC SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE Back to Search Results
Catalog Number 100040
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer reported during a procedure, the device did not inflate evenly and they could not get a seal.They had to use another size on the patient.No patient harm was reported.The patient's condition was unknown at the time of this report.
 
Event Description
Customer reported during a procedure, the device did not inflate evenly and they could not get a seal.They had to use another size on the patient.No patient harm was reported.The patient's condition was unknown at the time of this report.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LMA CLASSIC SIZE 4
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10364250
MDR Text Key205325145
Report Number9681900-2020-00010
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 company representative,user f
Type of Report Initial,Followup
Report Date 07/22/2020
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 Number100040
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/04/2020
Supplement Dates Manufacturer Received09/09/2020
Supplement Dates FDA Received09/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
-
-