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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 3 (150030); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 3 (150030); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 15130
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges the device will not deflate properly.Alleged malfunction reported as occurred during functional testing prior to a patient use.There was no report of patient impact or consequence.The patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4) the sample was returned for evaluation.A visual exam was performed and no defects were observed.The device could be inflated and deflated normally.Deflation was observed to be slightly sluggish when the red plug was opened; however, by a slight pinch on the sides of the red plug, the deflation improved.A device history record review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint could not be confirmed.The device was found to be functional and could be inflated and deflated using the check valve; however, deflation was sluggish with the red plug open.This could be due to inevitable expansion and contraction of the components material during logistics movement over time.
 
Event Description
Customer complaint alleges the device will not deflate properly.Alleged malfunction reported as occurred during functional testing prior to a patient use.There was no report of patient impact or consequence.The patient condition was reported as "fine".
 
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Brand Name
LMA PROSEAL, REU, SIZE 3 (150030)
Type of Device
AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key7621637
MDR Text Key112219999
Report Number9681900-2018-00029
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/05/2018
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 Catalogue Number15130
Device Lot NumberKFAAY6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Initial Date Manufacturer Received 06/05/2018
Initial Date FDA Received06/20/2018
Supplement Dates Manufacturer Received07/18/2018
Supplement Dates FDA Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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