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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 1D2040
Device Problems Shelf Life Exceeded (1567); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been received by the manufacturer.However the evaluation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of this investigation.
 
Event Description
Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.It was reported there was no complications or injury to the patient.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.Functional testing was performed the device was found to be within specification.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed the reported complaint could not be confirmed.
 
Event Description
Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.It was reported there was no complications or injury to the patient.Patient condition reported as "fine".
 
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Brand Name
LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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
9194334854
MDR Report Key6896759
MDR Text Key87453129
Report Number3011137372-2017-00283
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 company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/08/2017
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 Expiration Date11/30/2019
Device Catalogue Number1D2040
Device Lot NumberLQAFFR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2017
Initial Date FDA Received09/27/2017
Supplement Dates Manufacturer Received11/06/2017
Supplement Dates FDA Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2016
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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