CARDINAL HEALTH SBA56PUIMB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-06 for CARDINAL HEALTH SBA56PUIMB manufactured by Cardinal Health 200, Llc.

MAUDE Entry Details

Report Number8864231
MDR Report Key8864231
Date Received2019-08-06
Date of Report2019-07-19
Date of Event2019-07-10
Report Date2019-07-19
Date Reported to FDA2019-07-19
Date Reported to Mfgr2019-08-06
Date Added to Maude2019-08-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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
Generic NameENDOSCOPE INTRODUCER KIT
Product CodeNWU
Date Received2019-08-06
Model NumberSBA56PUIMB
Catalog NumberSBA56PUIMB
Lot Number216990
Device AvailabilityY
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 2019-08-06

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