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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD. LMA SUPREME , SU, SIZE 4; LARYNGEAL MASK AIRWAY
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TELEFLEX ASIA PTE LTD. LMA SUPREME , SU, SIZE 4; LARYNGEAL MASK AIRWAY Back to Search Results
Catalog Number 175040
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges the device failed to ventilate.There were several unsuccessful attempts to reposition.There was patient involvement, however, there was no reported harm to the patient.
 
Manufacturer Narrative
The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
LMA SUPREME , SU, SIZE 4
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TELEFLEX ASIA PTE LTD.
6 battery road, #07-02
0499 09
SN  049909
Manufacturer (Section G)
TELEFLEX ASIA PTE LTD
6 battery road, #07-02
0499 09
SN   049909
Manufacturer Contact
warrenda peterson
p.o. box 12600
durham, NC 27709
3613959
MDR Report Key3912381
MDR Text Key4488445
Report Number9681900-2014-00017
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number175040
Device Lot NumberHMADRG
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2014
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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