FDA Adverse Event
Injury
Summary report: N
DADE (R) COLAGEN/EPINEPHREINE (COL/EPI) TES CRTG
MDR report key: 645098
·
Received November 7, 2005
Report
- Report Number
- 9610806-2005-00031
- Event Type
- Injury
- Date Received
- November 7, 2005
- Date of Event
- June 14, 2005
- Report Date
- June 14, 2005
- Manufacturer
- DADE BEHRING GMBH
- Product Code
- GHR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A CLOSURE TIME OF 113 SECONDS WAS OBTAINED FOR A PT WHEN TESTEDUSING DADE PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE. PT BLED DURING SURGERY AND PT WAS GIVEN 6 UNITS OF PACKED CELLS. NO OTHER ISSUES REGARDING PT RECOVERY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DADE (R) COLAGEN/EPINEPHREINE (COL/EPI) TES CRTG | REAGENT, PLATELET AGGREGATION | GHR | DADE BEHRING GMBH | NA | 579543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Life Threatening| R |