CARDINAL HEALTH SMA12SEMWV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-09 for CARDINAL HEALTH SMA12SEMWV manufactured by Cardinal Health 200, Llc.

MAUDE Entry Details

Report Number8974820
MDR Report Key8974820
Date Received2019-09-09
Date of Report2019-08-16
Date of Event2019-07-27
Report Date2019-08-16
Date Reported to FDA2019-08-16
Date Reported to Mfgr2019-09-09
Date Added to Maude2019-09-09
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 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 NameCESAREAN SECTION TRAY
Product CodeOHM
Date Received2019-09-09
Model NumberSMA12SEMWV
Catalog NumberSMA12SEMWV
Lot Number538312
Device AvailabilityY
Device Age2 MO
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 2019-09-09

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