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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MED ASIA PTE LTD LMA FLEXIBLE, REU SIZE 5; LARYNGEAL MASK AIRWAY
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TELEFLEX MED ASIA PTE LTD LMA FLEXIBLE, REU SIZE 5; LARYNGEAL MASK AIRWAY Back to Search Results
Catalog Number 11150
Device Problem Material Rupture (1546)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the pilot balloon ruptured during inflation.The alleged issue occurred during the testing procedure prior to patient use.No patient injury/harm.No report of a delay in treatment to the patient.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
 
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Brand Name
LMA FLEXIBLE, REU SIZE 5
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TELEFLEX MED ASIA PTE LTD
6 battery rd, 07-02
0499 09
SN  049909
Manufacturer (Section G)
TELEFLEX MED ASIA PTE LTD
6 battery road, 07-02
0499 09
SN   049909
Manufacturer Contact
margie burton, rn
po box 1260
durham, NC 27709
9194334965
MDR Report Key3753010
MDR Text Key21997233
Report Number9681900-2014-00005
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11150
Device Lot Number9FPAASXH
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/21/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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