FDA Adverse Event
Other
Summary report: N
CELLEX
MDR report key: 1971968
·
Received January 24, 2011
Report
- Report Number
- 2523595-2011-00002
- Event Type
- Other
- Date Received
- January 24, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 24, 2011
- Manufacturer
- THERAKOS
- Product Code
- LNR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
PATIENT RECEIVED TREATMENT ON (B)(6) 2011. DURING THAT NIGHT, PATIENT EXPERIENCED HEMATURIA AND FEVER. THERE WAS NO EVIDENCE OF A URINARY TRACT INFECTION. THERE WERE NO RED CELLS SEEN ON THE MICROSCOPY OF THE URINE. PATIENT AGAIN RECEIVED TREATMENT THE FOLLOWING DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELLEX | CELLEX | LNR | THERAKOS | 6661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other |