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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1; LMA UNIQUE
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TELEFLEX MEDICAL LMA SUPREME SIZE 1; LMA UNIQUE Back to Search Results
Catalog Number ALBF010SU
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Event Description
It was reported that: prehospital in the patients' home, infant in cardiac arrest.Paramedic conducted a precheck of his equipment after opening the package for the size 1.0 lma.The device would not hold air and therefore, failed.Manual ventilations continued and the patient was oxygenated well.The air was leaking from inside the cuff.Associated to 3009307931-2024-00007.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: prehospital in the patients' home, infant in cardiac arrest.Paramedic conducted a precheck of his equipment after opening the package for the size 1.0 lma.The device would not hold air and therefore, failed.Manual ventilations continued and the patient was oxygenated well.The air was leaking from inside the cuff.Associated to 3009307931-2024-00007.
 
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.
 
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Brand Name
LMA SUPREME SIZE 1
Type of Device
LMA UNIQUE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
THE LARYNGEAL MASK COMPANY (M) SDN. BHD
lot 19 , jalan hi-tech 3
zon industri fasa 1, kulim hi-tech park
kulim kedah 09090
MY   09090
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18738012
MDR Text Key335739449
Report Number3009307931-2024-00006
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/25/2024
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 NumberALBF010SU
Device Lot Number11F21G0053
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/25/2024
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received02/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.
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