FDA Adverse Event
Injury
Summary report: N
PROSORBA COLUMN
MDR report key: 470053
·
Received July 2, 2003
Report
- Report Number
- 3032792-2003-00002
- Event Type
- Injury
- Date Received
- July 2, 2003
- Date of Event
- June 2, 2003
- Report Date
- July 1, 2003
- Manufacturer
- FRESENIUS HEMOCARE, INC.
- Product Code
- LQQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON WAY HOME AFTER THE FIRST PROSORBA TREATMENT, PT HAD CHEST PAIN. PT WAS HOSPITALIZED AND DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION. TREATED WITH THROMBOLYTIC MEASURES AND SURVEILLANCE IN ICU. TESTS REVEALED SEVERE CORONARY HEART DISEASE (3-VESSEL) WITH HIGH DEGREE OF STENOSIS OF RIVA, RD I AND II, RCX, AND RCA AND REDUCED GLOBAL FUNCTIONALITY (EJECTION FRACTION OF 34%). NO FURTHER PROSORBA TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSORBA COLUMN | PROSORBA COLUMN | LQQ | FRESENIUS HEMOCARE, INC. | 9798701 | NEN011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening | VIOXX| BISOPROLOL| NALOXON| VOLTAREN| DECORTIN |