LMA GASTRO CUFF PILOT SIZE 4 1E5040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-30 for LMA GASTRO CUFF PILOT SIZE 4 1E5040 manufactured by Teleflex Medical.

Event Text Entries

[152657271] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[152657272] It was reported that the balloon of the device was stuck in the larynx of the patient because the doctor was unable to deflate the balloon. The doctor has stated that it was user error as he acknowledged he did not use the correct syringe and did not follow the ifu guidelines. It was also reported that "during the incident he pulled on the device to remove the tube with the balloon inflated but there was no pain for any patient. " since the event, an in-service has been performed with the doctor. No patient injury/harm reported. The condition of the patient was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681900-2019-00033
MDR Report Key8841634
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-30
Date of Report2019-06-14
Date of Event2019-05-22
Date Mfgr Received2019-07-31
Date Added to Maude2019-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1THE LARYNGEAL MASK COMPANY
Manufacturer Street6 BATTERY ROAD #07-02
Manufacturer CitySINGAPORE 049909
Manufacturer CountrySN
Manufacturer Postal Code049909
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLMA GASTRO CUFF PILOT SIZE 4
Generic NameLMA GASTRO CUFF PILOT
Product CodeCAE
Date Received2019-07-30
Catalog Number1E5040
Lot NumberNMCPRQ
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention 2019-07-30

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