CARDINAL HEALTH STERILE PEDI T AND A PACK SEN51TALPD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for CARDINAL HEALTH STERILE PEDI T AND A PACK SEN51TALPD manufactured by Cardinal Health 200, Llc.

MAUDE Entry Details

Report Number9391734
MDR Report Key9391734
Date Received2019-11-29
Date of Report2019-11-26
Date of Event2019-11-19
Report Date2019-11-26
Date Reported to FDA2019-11-26
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDINAL HEALTH STERILE PEDI T AND A PACK
Generic NameEAR, NOSE, AND THROAT SURGICAL TRAY
Product CodeOGR
Date Received2019-11-29
Model NumberSEN51TALPD
Catalog NumberSEN51TALPD
Lot Number291697
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address785 FORT MILL HWY. FORT MILL SC 29707 US 29707


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.