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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 2.5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA SUPREME SIZE 2.5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 175025
Device Problem Inflation Problem (1310)
Patient Problem No Patient Involvement (2645)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges the balloon did not inflate prior to patient use during functional testing.No patient involvement reported.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer complaint alleges the balloon did not inflate prior to patient use during functional testing.No patient involvement reported.
 
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Brand Name
LMA SUPREME SIZE 2.5
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9522141
MDR Text Key182598137
Report Number9681900-2019-00052
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 12/02/2019
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 Expiration Date06/28/2022
Device Catalogue Number175025
Device Lot NumberPMBSBH
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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