FLEXIBLE YANKAUER REGULAR CAPA 8888501015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-10-31 for FLEXIBLE YANKAUER REGULAR CAPA 8888501015 manufactured by Covidien.

MAUDE Entry Details

Report Number9611018-2019-00358
MDR Report Key9263276
Report SourceFOREIGN,USER FACILITY
Date Received2019-10-31
Date of Report2019-10-31
Date of Event2019-10-07
Date Mfgr Received2019-10-22
Date Added to Maude2019-10-31
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetSRAGH INDUSTRIAL ESTATE, CO, T
Manufacturer CityOFFALY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIBLE YANKAUER REGULAR CAPA
Generic NameAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Product CodeGCX
Date Received2019-10-31
Model Number8888501015
Catalog Number8888501015
Lot Number19A152FHX
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressSRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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