FDA Adverse Event
Death
Summary report: N
CELLEX
MDR report key: 1831784
·
Received September 10, 2010
Report
- Report Number
- 2523595-2010-00010
- Event Type
- Death
- Date Received
- September 10, 2010
- Date of Event
- August 25, 2010
- Report Date
- September 3, 2010
- Manufacturer
- THERAKOS
- Product Code
- LNR
- PMA / PMN Number
- P860003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT IS UNLIKELY THE ECP TREATMENT CONTRIBUTED TO THE DEATH AS THE UNDERLYING DIAGNOSIS OF PT WAS DESCRIBED AS BEING THE POTENTIAL CAUSE. THE CUSTOMER AGREED TO RETURN THE DATA FILE TO CONFIRM APPROPRIATE OPERATION. (B)(4).
Description of Event or Problem · 1
THE PT WAS BEING TREATED FOR GVHD. HER LAST TREATMENT WAS ON (B)(6)2010. THE ATTENDING PHYSICIAN REPORTED, THE DEATH APPEARED TO BE A RESULT OF THE UNDERLYING CONDITION OF THE PT, AND NOT THE TREATMENT NOR THE ADMINISTRATION OF METHOXSALEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELLEX | CELLEX | LNR | THERAKOS | CELLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Death | UVADEX, PER ECP TREATMENT, LOT# 1831401| METHOXSALEN |