LARYSEAL CLEAR LARYNGEAL MASK AIRWAY SIZE 5 038-94-350U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-14 for LARYSEAL CLEAR LARYNGEAL MASK AIRWAY SIZE 5 038-94-350U manufactured by Flexicare Medical Dongguan Ltd..

MAUDE Entry Details

Report Number3006061749-2019-00012
MDR Report Key9320478
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-14
Date of Report2019-11-05
Date of Event2019-10-03
Date Mfgr Received2019-10-07
Device Manufacturer Date2017-05-01
Date Added to Maude2019-11-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR RICHARD DOWNS
Manufacturer StreetCYNON VALLEY BUSINESS PARK
Manufacturer CityMOUNTAIN ASH, CF454ER
Manufacturer CountryUK
Manufacturer PostalCF45 4ER
Manufacturer G1FLEXICARE MEDICAL DONGGUAN LTD.
Manufacturer StreetNO. B-15 XICHENG IND ZONE 1 HENGLI TOWN
Manufacturer CityDONGGUAN CITY, 523460
Manufacturer CountryCH
Manufacturer Postal Code523460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLARYSEAL CLEAR LARYNGEAL MASK AIRWAY SIZE 5
Generic NameLARYNGEAL MASK AIRWAY (LMA)
Product CodeCAE
Date Received2019-11-14
Catalog Number038-94-350U
Lot Number170501396
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFLEXICARE MEDICAL DONGGUAN LTD.
Manufacturer AddressNO. B-15 XICHENG IND ZONE 1 HENGLI TOWN DONGGUAN CITY, 523460 CH 523460


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-14

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