FDA Adverse Event
Injury
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1288465
·
Received January 13, 2009
Report
- Report Number
- 2248721-2009-00002
- Event Type
- Injury
- Date Received
- January 13, 2009
- Date of Event
- December 20, 2008
- Report Date
- January 13, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K010599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT INFORMATION COMMUNICATED TO ITC VIA INDEPENDENT DIAGNOSTIC TREATMENT FACILITY (IDTF). ITC WILL INVESTIGATE FURTHER BY DIRECT CONTACT WITH CUSTOMER. MFR METHOD - OTHER: MFR EVALUATION / INVESTIGATION CURRENTLY IN PROGRESS. RESULTS - INVESTIGATION CURRENTLY IN PROGRESS.
Description of Event or Problem · 1
CUSTOMER REPORTS SPOUSE REQUIRED ER TREATMENT FOR NOSEBLEED. SUCCESSFULLY TREATED WITH COMPRESSION AND SUBSEQUENTLY RELEASED. WHILE IN ER, LABORATORY INR WAS 6.7. UPON RETURNING HOME, SPOUSE SELF-TESTED WITH PROTIME WITH INR RESULT OF 3.2. COUMADIN DOSE SUBSEQUENTLY REVISED BASED ON LABORATORY INR. THE PATIENT'S THERAPEUTIC RANGE IS 3.0 - 3.5. NO FURTHER REPORTS OF SUBSEQUENT ADVERSE EVENTS OR INJURIES REQUIRING MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT / 3 CHANNEL CUVETTE | JPA | INTERNATIONAL TECHNIDYNE CORP. | L11- 01- 01C | L8P3C431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |