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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ASIA PTE LTD LMA SURE SEAL, SU, SILICONE CUFF, SIZE 5; LARYNGEAL MASK AIRWAY
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TELEFLEX MEDICAL ASIA PTE LTD LMA SURE SEAL, SU, SILICONE CUFF, SIZE 5; LARYNGEAL MASK AIRWAY Back to Search Results
Catalog Number 105300-000050
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that they were unable to deflate the device via the valve.The user was obligated to perforate the pilot balloon.No report of pt injury.
 
Manufacturer Narrative
The device sample was not returned for eval at the time of this report.
 
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Brand Name
LMA SURE SEAL, SU, SILICONE CUFF, SIZE 5
Type of Device
LARYNGEAL MASK AIRWAY
Manufacturer (Section D)
TELEFLEX MEDICAL ASIA PTE LTD
6 battery rd
#07-02
singapore 0499 09
Manufacturer (Section G)
TELEFLEX MEDICAL ASIA PTE LTD
6 battery rd
#07-02
singapore 0499 09
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3865294
MDR Text Key4590188
Report Number9681900-2014-00006
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/17/2014
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 Number105300-000050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/17/2014
Initial Date FDA Received02/07/2014
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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