HEMOCHRON RESPONSE SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-09-10 for HEMOCHRON RESPONSE SYSTEM manufactured by International Technidyne Corp..

Event Text Entries

[1399430] Hemochron response test well #1 at 700 seconds while test well #2 at 500 seconds. Procedure, therapeutic range for procedure, and baseline not reported. No report of adverse event, serious injury, or intervention.
Patient Sequence No: 1, Text Type: D, B5


[8657553] (b)(4). Customer evaluation reported: esv conducted with acceptable results. Liquid eqc conducted with acceptable results. Mfr eval / investigation pending add'l info from consumer. Mfr method, results, conclusions: mfr eval / investigation pending add'l info from consumer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2248721-2009-00425
MDR Report Key1711732
Report Source01,05,08
Date Received2009-09-10
Date of Report2009-08-25
Date of Event2007-10-11
Date Mfgr Received2009-07-21
Device Manufacturer Date2007-06-01
Date Added to Maude2010-10-01
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 FDA0
Event Location0
Manufacturer ContactDAVID GRONOSTAJSKI
Manufacturer Street8 OLSEN AVE.
Manufacturer CityEDISON NJ 08820
Manufacturer CountryUS
Manufacturer Postal08820
Manufacturer Phone7325485700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOCHRON RESPONSE SYSTEM
Generic NameRESPONSE INST / TUBE
Product CodeKQG
Date Received2009-09-10
Model NumberRESPONSE
Catalog NumberRESPONSE
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer AddressEDISON NJ 08820 US 08820


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-09-10

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