AQUA-SEAL CDU 8888571299

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 2019-08-20 for AQUA-SEAL CDU 8888571299 manufactured by Covidien.

MAUDE Entry Details

Report Number9611018-2019-00315
MDR Report Key8913350
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-20
Date of Report2019-10-14
Date of Event2019-08-09
Date Mfgr Received2019-08-09
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 StreetSRAGH INDUSTRIAL ESTATE, CO, T
Manufacturer CityOFFALY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUA-SEAL CDU
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2019-08-20
Model Number8888571299
Catalog Number8888571299
Lot Number18F133FHX
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressSRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-20

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