CONVERTORS 9515

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-05 for CONVERTORS 9515 manufactured by Cardinal Health 200, Llc.

MAUDE Entry Details

Report Number8669752
MDR Report Key8669752
Date Received2019-06-05
Date of Report2019-05-22
Date of Event2019-05-09
Report Date2019-05-22
Date Reported to FDA2019-05-22
Date Reported to Mfgr2019-06-05
Date Added to Maude2019-06-05
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 NameCONVERTORS
Generic NameGOWN, SURGICAL
Product CodeFYA
Date Received2019-06-05
Model Number9515
Catalog Number9515
Lot Number18LWQ004
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-05

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