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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL; AIRWAY, OROPHARYNGEAL, ANESTH
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TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL; AIRWAY, OROPHARYNGEAL, ANESTH Back to Search Results
Model Number IPN922773
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
Event Type  malfunction  
Event Description
Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.
 
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Manufacturer Narrative
Qn#(b)(4).The device history was reviewed and there was no abnormality found.Based on the complaint description of "will not deflate prior to use", reviewing of the dhr of the packaging and assembly lot, reviewing the nc list, it was concluded that the complaint root cause is undetermined / unknown as the assembly or packaging process for the affected lot manufacturing process did not have any record on the similar issue.Further investigation shall be performed once the complaint sample was returned to kulim.
 
Event Description
Reported issue: the cuff stayed in the red zone when inflated then it was unable to be inflated or deflated with syringe.The defect was detected just before insertion into the patient.The intervention was to grab another one and keep bagging.
 
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Brand Name
LMA UNIQUE (SILICONE CUFF) AND LMA UNIQUE (SIL
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTH
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
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16085635
MDR Text Key306643063
Report Number9681900-2023-00001
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeCA
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 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN922773
Device Catalogue Number105200-000050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
Patient Outcome(s) Required Intervention;
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