MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-09-28 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. 110 manufactured by International Technidyne Corp..
[15409578]
Healthcare provider reports the hemochron response instrument is "not detecting a clot". Customer could not confirm that an actual clot had formed in the assay tube. No adverse event reported. This event occurred outside the united states.
Patient Sequence No: 1, Text Type: D, B5
[15793096]
(b)(4). Manufacturer awaiting product return for further complaint evaluation.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2248721-2010-00143 |
MDR Report Key | 1864818 |
Report Source | 01,05 |
Date Received | 2010-09-28 |
Date of Report | 2010-09-28 |
Date of Event | 2010-09-01 |
Date Mfgr Received | 2010-09-16 |
Date Added to Maude | 2011-03-01 |
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 | 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 |
Brand Name | HEMOCHRON RESPONSE COAGULATION SYSTEM |
Generic Name | HEMOCHRON RESPONSE COAGULATION ANALYZER |
Product Code | KQG |
Date Received | 2010-09-28 |
Model Number | HRS. 110 |
Catalog Number | HRS. 110 |
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 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-09-28 |