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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4
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TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 4 Back to Search Results
Model Number IPN922818
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported "dr.Placed size 5, seated fine and went to squeeze bag and just insufflated stomach.Tried again and same thing happened.Repeated the process twice with a size 4 and same thing happened.Ended up intubating patient".No patient injury or harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "dr.Placed size 5, seated fine and went to squeeze bag and just insufflated stomach.Tried again and same thing happened.Repeated the process twice with a size 4 and same thing happened.Ended up intubating patient".No patient injury or harm reported.Patient condition reported as "fine".
 
Event Description
It was reported "[dr.] placed size 5, seated fine and went to squeeze bag and just insulflated stomach.Tried again and same thing happened.Repeated the process twice with a size 4 and same thing happened.Ended up intubating patient".No patient injury or harm reported.Patient condition reported as "fine".
 
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 PROTECTOR CUFF PILOT SIZE 4
Type of Device
LMA PROTECTOR
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
MDR Report Key13497690
MDR Text Key286139199
Report Number9681900-2022-00007
Device Sequence Number1
Product Code CAE
UDI-Device Identifier15060112317993
UDI-Public15060112317993
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 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2023
Device Model NumberIPN922818
Device Catalogue Number192040
Device Lot NumberQMDCM5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2020
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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