FDA Adverse Event
Other
Summary report: N
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
MDR report key: 2011785
·
Received February 22, 2011
Report
- Report Number
- 2523595-2011-00004
- Event Type
- Other
- Date Received
- February 22, 2011
- Date of Event
- December 23, 2010
- Report Date
- February 22, 2011
- Manufacturer
- THERAKOS
- Product Code
- LNR
- PMA / PMN Number
- P860003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO REPORTS OF A DEVICE MALFUNCTION HAVE BEEN RECEIVED TO DATE AS IT RELATES TO THIS EVENT. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED EXTENDED HOSP STAY DUE TO ACUTE GVHD REACTION. PT HAD TWO WEEKS NON-MUCOID WATERY DIARRHEA WHICH AGGRAVATED CLEARLY SEVEN DAYS PRIOR WITH ANOREXIA AND ABDOMINAL PAIN. DESPITE A TREATMENT STARTED ON (B)(6) 2010, THE DECISION OF EXTENDED STAY WAS TAKEN ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM | XTS ECP TREATMENT | LNR | THERAKOS | XTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| O |