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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA SUPREME SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 175050
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint is reported as: "the lma supreme was used for years and the anaesthesist is familiar with use of this device.In (b)(6) 2019 on 3 devices used on 3 different patients it was noted that the shape was changed and the masks didn't fit correctly anymore.Thus the masks did not seal correctly and the opening for the esophagus lied in the trachea.In each case a laryngeal mask from a competitor was used successfully.Patient was not injured and the devices were disposed.No further details available".
 
Event Description
The complaint is reported as: "the lma supreme was used for years and the anaesthesist is familiar with use of this device.In (b)(6) 2019 on 3 devices used on 3 different patients it was noted that the shape was changed and the masks didn't fit correctly anymore.Thus the masks did not seal correctly and the opening for the esophagus lied in the trachea.In each case a laryngeal mask from a competitor was used successfully.Patient was not injured and the devices were disposed.No further details available".
 
Manufacturer Narrative
(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.
 
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Brand Name
LMA SUPREME SIZE 5
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8663728
MDR Text Key146939309
Report Number9681900-2019-00013
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 05/09/2019
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 Health Professional
Device Catalogue Number175050
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/09/2019
Initial Date FDA Received06/03/2019
Supplement Dates Manufacturer Received06/26/2019
Supplement Dates FDA Received06/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED.
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