TOWEL OR 17X24IN GREEN STERILE 4/PK 28200-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for TOWEL OR 17X24IN GREEN STERILE 4/PK 28200-004 manufactured by Cardinal Health Shanghai.

MAUDE Entry Details

Report Number1423537-2020-00438
MDR Report Key9857934
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2020-01-23
Date Facility Aware2020-02-19
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-19
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 ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DR.
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874152
Manufacturer G1CARDINAL HEALTH SHANGHAI
Manufacturer StreetF20, TOWER 1, KERRY EVERBRIGHT
Manufacturer CitySHANGHAI 200070
Manufacturer CountryCH
Manufacturer Postal Code200070
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOWEL OR 17X24IN GREEN STERILE 4/PK
Generic NameGENERAL SURGERY TRAY (KIT)
Product CodeLRO
Date Received2020-03-19
Model Number28200-004
Catalog Number28200-004
Lot Number190924-04-SH
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH SHANGHAI
Manufacturer AddressF20, TOWER 1, KERRY EVERBRIGHT SHANGHAI 200070 CH 200070


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.