EVAC STATION ULEV100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-08 for EVAC STATION ULEV100 manufactured by Dornoch.

MAUDE Entry Details

Report Number0001954182-2019-00072
MDR Report Key9295793
Report SourceUSER FACILITY
Date Received2019-11-08
Date of Report2019-11-07
Date of Event2019-10-16
Date Mfgr Received2019-10-16
Device Manufacturer Date2016-08-20
Date Added to Maude2019-11-08
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 NameEVAC STATION
Generic NameAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Product CodeJCX
Date Received2019-11-08
Catalog NumberULEV100
Lot Number0023155
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-11-08

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