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..
[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
Report Number | 2248721-2009-00425 |
MDR Report Key | 1711732 |
Report Source | 01,05,08 |
Date Received | 2009-09-10 |
Date of Report | 2009-08-25 |
Date of Event | 2007-10-11 |
Date Mfgr Received | 2009-07-21 |
Device Manufacturer Date | 2007-06-01 |
Date Added to Maude | 2010-10-01 |
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 | DAVID GRONOSTAJSKI |
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 |
Brand Name | HEMOCHRON RESPONSE SYSTEM |
Generic Name | RESPONSE INST / TUBE |
Product Code | KQG |
Date Received | 2009-09-10 |
Model Number | RESPONSE |
Catalog Number | RESPONSE |
Lot Number | UNK |
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 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2009-09-10 |