FDA Adverse Event
Other
Summary report: N
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
MDR report key: 2011783
·
Received February 22, 2011
Report
- Report Number
- 2523595-2011-00008
- Event Type
- Other
- Date Received
- February 22, 2011
- Date of Event
- February 10, 2011
- 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
- MI, US
- Reporter Occupation
- OTHER
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
AT THE COMPLETION OF CYCLE 2, THE PATIENT COMPLAINED OF CHEST PAIN AND MILD SHORTNESS OF BREATH. PULSE OXIMITRY AND VITAL SIGNS WERE ALL WITHIN NORMAL RANGE. CUSTOMER STATED THAT THE PROCEDURE WAS ABORTED BECAUSE THE PATIENT IS FRAGILE. PATIENT WAS GIVEN 500ML BOLUS OF SALINE DISTRIBUTED OVER 1 HOUR AND WAS FINE AFTERWARDS.
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 | Other | METHOXSALEN: PER ECP TREATMENT| UVADEX: PER ECP TREATMENT, LOT #1935004 |