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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE
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TELEFLEX MEDICAL LMA FLEXIBLE SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE Back to Search Results
Catalog Number 110040
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported "the issue with the flexible size 4 lma is that it does not hold its seal.Once inflated it looses air slowly and does not maintain the volume of air injected".No patient involvement reported.
 
Event Description
It was reported "the issue with the flexible size 4 lma is that it does not hold its seal.Once inflated it looses air slowly and does not maintain the volume of air injected".No patient involvement reported.
 
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.
 
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Brand Name
LMA FLEXIBLE SIZE 4
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key11957581
MDR Text Key257242450
Report Number9681900-2021-00017
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 05/18/2021
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 No Information
Device Catalogue Number110040
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/18/2021
Initial Date FDA Received06/08/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.; N/A.
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