9575

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for 9575 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[143989199] Blood got through md's gown and onto his scrubs and lead that he was wearing for a tha. The gowns that we currently use are supposed to be impermeable, but this is happening quite frequently with his tha.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8577228
MDR Report Key8577228
Date Received2019-05-03
Date of Report2019-04-24
Date of Event2019-04-15
Report Date2019-04-24
Date Reported to FDA2019-04-24
Date Reported to Mfgr2019-05-03
Date Added to Maude2019-05-03
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

Generic NameGOWN, SURGICAL
Product CodeFYA
Date Received2019-05-03
Model Number9575
Catalog Number9575
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address7000 CARDINAL PLACE DUBLIN OH 43017 US 43017


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-03

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