INJECTOR, OPTIVANTAGE DH W/RFID 844003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-28 for INJECTOR, OPTIVANTAGE DH W/RFID 844003 manufactured by Liebel-flarsheim.

MAUDE Entry Details

Report Number1518293-2019-00012
MDR Report Key8744584
Date Received2019-06-28
Date of Report2019-05-28
Date of Event2019-05-14
Date Mfgr Received2019-05-28
Device Manufacturer Date2013-06-30
Date Added to Maude2019-06-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactFRED RECKELHOFF
Manufacturer Street2111 E GALBRAITH ROAD
Manufacturer CityCINCINNATI OH 45237
Manufacturer CountryUS
Manufacturer Postal45237
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINJECTOR, OPTIVANTAGE DH W/RFID
Generic NameINJECTOR, OPTIVANTAGE DH W/RFID
Product CodeIZQ
Date Received2019-06-28
Model Number844003
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM
Manufacturer Address2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-28

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