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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA PROSEAL SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Model Number IPN042498
Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported "a brand new lma proseal #4 was opened to use for inspection/functional testing.The nurse at clinic found the cuff had difficulty of deflating/inflating.It seems something wrong with its red plug".No patient involvement reported.
 
Event Description
It was reported "a brand new lma proseal #4 was opened to use for inspection/functional testing.The nurse at clinic found the cuff had difficulty of deflating/inflating.It seems something wrong with its red plug".No patient involvement reported.2 mdrs submitted: 9681900-2021-00022 - difficult to deflate cuff on device; 9681900-2021-00021 - difficult to inflate cuff on device.
 
Manufacturer Narrative
Qn# (b)(4).The device was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: "the device can be deflated and inflated with the check valve.Air releasing via red plug is sluggish.There was no usage record card to indicate the date of initial use and last use of the device.The date of reprocessing the device, reprocessing details and autoclave parameter is unknown.The root cause of the incident is unidentifiable." corrected data: section f10: medical device problem code corrected to 1149.Section h6: medical device problem code corrected to 1149.
 
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Brand Name
LMA PROSEAL SIZE 4
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTH
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key12246354
MDR Text Key264097320
Report Number9681900-2021-00022
Device Sequence Number1
Product Code CAE
UDI-Device Identifier04026704319688
UDI-Public04026704319688
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 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN042498
Device Catalogue Number150040
Device Lot Number8VUAN7R2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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