LUKI ASP TUBES 61/4 8886864604

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-08-20 for LUKI ASP TUBES 61/4 8886864604 manufactured by Covidiein.

MAUDE Entry Details

Report Number1282497-2019-08613
MDR Report Key8911097
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-08-20
Date of Report2019-08-20
Date of Event2019-08-15
Date Mfgr Received2019-08-15
Date Added to Maude2019-08-20
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 Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLUKI ASP TUBES 61/4
Generic NameCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
Product CodeKDH
Date Received2019-08-20
Model Number8886864604
Catalog Number8886864604
Lot Number182710205
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEIN
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-20

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