HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-15 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110 manufactured by International Technidyne Corporation.

Event Text Entries

[19621695] (b)(4). Method, result, conclusion: mfr/eval/investigation pending product return from user facility. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[19661365] Healthcare professional reports hemochron response instrument gave an unexpected act of 1200 and then gave an expected act result of 506. No adverse events reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2248721-2010-00166
MDR Report Key1942143
Report Source05,06
Date Received2010-11-15
Date of Report2010-10-18
Date Mfgr Received2010-10-18
Date Added to Maude2012-01-18
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 ContactLAWRENCE PICCIANO
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 COAGULATION SYSTEM
Generic NameHEMOCHRON RESPONSE COAGULATION ANALYZER
Product CodeKQG
Date Received2010-11-15
Model NumberHRS.110
Catalog NumberHRS.110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL TECHNIDYNE CORPORATION
Manufacturer AddressEDISON NJ 08820 US 08820


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-15

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