DUO FLUID CART 00514010100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-13 for DUO FLUID CART 00514010100 manufactured by Dornoch.

MAUDE Entry Details

Report Number0001954182-2020-00002
MDR Report Key9581207
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-13
Date of Report2020-01-23
Date of Event2019-12-18
Date Mfgr Received2020-01-17
Device Manufacturer Date2017-05-08
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1DORNOCH
Manufacturer Street200 NORTHWEST PARKWAY
Manufacturer CityRIVERSIDE MO 64150
Manufacturer CountryUS
Manufacturer Postal Code64150
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameDUO FLUID CART
Generic NameAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Product CodeJCX
Date Received2020-01-13
Catalog Number00514010100
Lot Number0024489
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDORNOCH
Manufacturer Address200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

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