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 GASTRO CUFF PILOT SIZE 5; 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 GASTRO CUFF PILOT SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTHE Back to Search Results
Model Number IPN046947
Device Problem Incorrect Measurement (1383)
Patient Problem Unspecified Gastrointestinal Problem (4491)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that "consultant (b)(6) was using a size 5 lma gastro and the cuff manometer gage failed".No patient injury reported.Additional information reported states that "the device [was] removed in its entirety".Patient condition reported as "fine".
 
Event Description
It was reported that "consultant (b)(6) was using a size 5 lma gastro and the cuff manometer gage failed".No patient injury reported.Additional information reported states that "the device [was] removed in its entirety".Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LMA GASTRO CUFF PILOT SIZE 5
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key12019225
MDR Text Key257242971
Report Number9681900-2021-00019
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,foreig
Type of Report Initial,Followup
Report Date 05/27/2021
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 Health Professional
Device Expiration Date07/28/2023
Device Model NumberIPN046947
Device Catalogue Number1E5050
Device Lot NumberQMCAGK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received06/17/2021
Supplement Dates Manufacturer Received07/14/2021
Supplement Dates FDA Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-