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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4
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TELEFLEX MEDICAL LMA UNIQUE SIZE 4 Back to Search Results
Model Number IPN922801
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2023
Event Type  malfunction  
Event Description
It was reported that while in use on a patient, "experienced a pressure leak, not good enough seal to maintain proper ventilation.The lma was removed as soon as doctor experienced the leak in the system, before desaturation.They removed the lma and inserted an ett.They were not monitoring the cuff pressure, but confirmed air in pilot balloon." no patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
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.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that while in use on a patient, "experienced a pressure leak, not good enough seal to maintain proper ventilation.The lma was removed as soon as doctor experienced the leak in the system, before desaturation.They removed the lma and inserted an ett.They were not monitoring the cuff pressure, but confirmed air in pilot balloon." no patient harm or injury.The patient status is reported as "fine".
 
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Brand Name
LMA UNIQUE SIZE 4
Type of Device
LMA UNIQUE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
THE LARYNGEAL MASK COMPANY
6 battery road #07-02
4 kamunting industrial estate
singapore 04990 9
SN   049909
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17371783
MDR Text Key319510151
Report Number8040412-2023-00297
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15060112318037
UDI-Public15060112318037
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/05/2023
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 Model NumberIPN922801
Device Catalogue Number125040
Device Lot Number11F22A0050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/05/2023
Initial Date FDA Received07/21/2023
Supplement Dates Manufacturer Received08/30/2023
Supplement Dates FDA Received08/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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