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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
Catalog Number 175030
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as: "on (b)(6) 2019, the juncture of the mechanical end was found not tight prior to the patient".No patient involvement.
 
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.
 
Event Description
The complaint is reported as: "4th jan 2019, the juncture of the mechanical end was found not tight prior to the patient." no patient involvement.
 
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Brand Name
LMA SUPREME SIZE 3
Type of Device
LMA SUPREME
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8587900
MDR Text Key145631784
Report Number9681900-2019-00009
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 04/13/2019
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 Date02/28/2021
Device Catalogue Number175030
Device Lot NumberNMAP6Z
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2019
Initial Date FDA Received05/07/2019
Supplement Dates Manufacturer Received05/30/2019
Supplement Dates FDA Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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