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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
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TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY Back to Search Results
Catalog Number 15140
Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is in progress.
 
Event Description
Customer complaint alleges that "an anesthesiologist placed the #4 lma in a patient.He was not getting a good seal and continued to inflate.Finally he decided to take it out and intubate instead.When he did so, the lma came out inflated in the wrong place." it was reported that the patient was sent home in good condition.
 
Manufacturer Narrative
(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and no issues were observed.The actual device was compared to a retained sample at the manufacturing facility.There were no significant differences between the two devices.Both samples were inflated and deflated and no issues were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.
 
Event Description
Customer complaint alleges that "an anesthesiologist placed the #4 lma in a patient.He was not getting a good seal and continued to inflate.Finally he decided to take it out and intubate instead.When he did so, the lma came out inflated in the wrong place." it was reported that the patient was sent home in good condition.
 
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Brand Name
LMA PROSEAL, REU, SIZE 4 (150040)
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 Key6608946
MDR Text Key76661537
Report Number9681900-2017-00027
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,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number15140
Device Lot Number8VRAT8HD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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