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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 5; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 5; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Model Number IPN923480
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "two lmas opened today appeared to have loose excess material at the airway entrance.They managed to remove the piece out of the tube".Associated complaints 3009307931-2024-00010 and 3009307931-2024-00009.
 
Event Description
It was reported that: "two lmas opened today appeared to have loose excess material at the airway entrance.They managed to remove the piece out of the tube".Associated complaints 3009307931-2024-00010 and 3009307931-2024-00009.
 
Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for evaluation.The manufacturer reported: "there are no actual complaint sample returned for further investigation of the foreign material.From the photo above, the foreign material in the red circle was unable to be identified.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.This complaint is concluded as "undetermined" as the foreign marking was unable to be identified from the photo attached and there is no sample received.Further investigation shall be carried out once the complaint sample is returned." teleflex will continue to monitor and trend on complaints of this nature.
 
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Brand Name
LMA UNIQUE (SILICONE) CUFF PILOT 5
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTH
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
THE LARYNGEAL MASK COMPANY (M) SDN. BHD
lot 19 , jalan hi-tech 3
zon industri fasa 1, kulim hi-tech park
kulim kedah 09090
MY   09090
Manufacturer Contact
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19002726
MDR Text Key338884992
Report Number3009307931-2024-00010
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/06/2024
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 Health Professional
Device Model NumberIPN923480
Device Catalogue Number105200-000050
Device Lot Number11F23B0157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received03/29/2024
Supplement Dates Manufacturer Received04/04/2024
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2023
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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