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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD LMA FASTRACH ETT, SU, SIZE 8.0; LARYNGEAL MASK AIRWAY
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TELEFLEX ASIA PTE LTD LMA FASTRACH ETT, SU, SIZE 8.0; LARYNGEAL MASK AIRWAY Back to Search Results
Catalog Number 136080
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Date 06/03/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges the et tube was sticking on the distal end of the airway device and was unable to advance the et tube.The reported defect was detected during a product demonstration.There was no pt involvement.
 
Manufacturer Narrative
The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
LMA FASTRACH ETT, SU, SIZE 8.0
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TELEFLEX ASIA PTE LTD
6 battery road, #07-02
singapore 0499 09
SN  049909
Manufacturer (Section G)
TELEFLEX ASIA PTE LTD
6 battery roard, #07-02
singapore 0499 09
SN   049909
Manufacturer Contact
warrenda peterson
p.o. box 12600
durham, NC 27709
9193613959
MDR Report Key4074101
MDR Text Key4897656
Report Number9681900-2014-00030
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 Not Applicable
Type of Report Initial
Report Date 06/03/2014
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 Catalogue Number136080
Device Lot NumberGBAA56
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/03/2014
Initial Date FDA Received06/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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