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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3
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TELEFLEX MEDICAL LMA SUPREME SIZE 3 Back to Search Results
Model Number IPN922810
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 06/17/2022
Event Type  malfunction  
Event Description
Complaint reported that: "using the cvc they realized it was broken.After placing the mask on the patient, the medical personnel realized that mask had a leak in the balloon, the nursing personnel removed the mask and requested a device change.The incident caused a delay in patient care.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Complaint reported that: "using the cvc they realized it was broken.After placing the mask on the patient, the medical personnel realized that mask had a leak in the balloon, the nursing personnel removed the mask and requested a device change.The incident caused a delay in patient care.
 
Manufacturer Narrative
Qn# (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 SUPREME SIZE 3
Type of Device
LMA SUPREME
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
THE LARYNGEAL MASK COMPANY
6 battery road #07-02
singapore 04990 9
SN   049909
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key15145206
MDR Text Key302771227
Report Number9681900-2022-00026
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15060112318082
UDI-Public15060112318082
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN922810
Device Catalogue Number175030
Device Lot Number11F21F0103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2021
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
N/A.; N/A.
Patient Age10 YR
Patient SexMale
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