HEMOCHRON RXDX 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 report with the FDA on 2009-09-10 for HEMOCHRON RXDX SYSTEM HRS. 110 manufactured by International Technidyne Corp..

Event Text Entries

[16092264] (b)(4). 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


[16255074] The 36 seconds from assay in one test well of hemochron response sys vs 585 seconds from same assay in second test well. No report of adverse event, serious injury, or intervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2248721-2009-00509
MDR Report Key1712023
Report Source05
Date Received2009-09-10
Date of Report2009-08-27
Date of Event2008-08-15
Date Mfgr Received2009-07-21
Device Manufacturer Date2004-11-01
Date Added to Maude2010-08-21
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 RXDX SYSTEM
Generic NameRESPONSE INST / TUBE
Product CodeKQG
Date Received2009-09-10
Model NumberHRS. 110
Catalog NumberHRS. 110
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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