MEDICHOICE SPCT1002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for MEDICHOICE SPCT1002 manufactured by Owens & Minor Distribution Inc..

MAUDE Entry Details

Report Number8955445
MDR Report Key8955445
Date Received2019-09-03
Date of Report2019-07-31
Date of Event2019-07-25
Report Date2019-07-31
Date Reported to FDA2019-07-31
Date Reported to Mfgr2019-09-03
Date Added to Maude2019-09-03
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 NameMEDICHOICE
Generic NameTRAY, SURGICAL
Product CodeLRP
Date Received2019-09-03
Model NumberSPCT1002
Catalog NumberSPCT1002
Lot Number1902LY09A
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOWENS & MINOR DISTRIBUTION INC.
Manufacturer Address11900 NORTH LAKERIDGE PKWY ASHLAND VA 23005 US 23005


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-03

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