FDA Adverse Event
Death
Summary report: N
EMBOSPHERE MICROSPHERES
MDR report key: 414955
·
Received September 4, 2002
Report
- Report Number
- 1226551-2002-00008
- Event Type
- Death
- Date Received
- September 4, 2002
- Date of Event
- July 1, 2002
- Report Date
- September 4, 2002
- Manufacturer
- BIOSPHERE MEDICAL S.A./BAT A - PARC DES NATIONS
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPIRED SHORTLY AFTER UNDERGOING AN EMBOLIZATION PROCEDURE FOR TREATMENT OF LIVER CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMBOSPHERE MICROSPHERES | ARTIFICIAL EMBOLIZATION DEVICE | HCG | BIOSPHERE MEDICAL S.A./BAT A - PARC DES NATIONS | 40-120,100-300,300-500 MICRON | MULTIPLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |