HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110-D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-08-04 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS.110-D manufactured by International Technidyne Corp..

Event Text Entries

[1628003] Customer reports "run-on" problems with the hemochron response system.
Patient Sequence No: 1, Text Type: D, B5

[8728577] (b)(4). Manufacturer awaiting product return for further complaint investigation.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2248721-2010-00120
• MDR Report Key: 1791881
• Report Source: 05,08
• Date Received: 2010-08-04
• Date of Report: 2010-08-04
• Date of Event: 2010-07-01
• Date Mfgr Received: 2010-07-28
• Date Added to Maude: 2011-01-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: LAWRENCE PICCIANO
• Manufacturer Street: 8 OLSEN AVE.
• Manufacturer City: EDISON NJ 08820
• Manufacturer Country: US
• Manufacturer Postal: 08820
• Manufacturer Phone: 7325485700
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEMOCHRON RESPONSE COAGULATION SYSTEM
• Generic Name: HEMOCHRON RESPONSE COAGULATION ANALYZER
• Product Code: KQG
• Date Received: 2010-08-04
• Model Number: HRS.110-D
• Catalog Number: HRS.110-D
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTERNATIONAL TECHNIDYNE CORP.
• Manufacturer Address: EDISON NJ 08820 US 08820

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-08-04