FDA Adverse Event
Injury
Summary report: N
SIEMENS
MDR report key: 52133
·
Received August 8, 1996
Report
- Report Number
- 52133
- Event Type
- Injury
- Date Received
- August 8, 1996
- Date of Event
- February 23, 1996
- Report Date
- March 13, 1996
- Manufacturer
- SIEMENS
- Product Code
- FFK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
STENT TO BE PLACED IN SOLITARY KIDNEY TO BLAST STONE. PT HAD MUCH PAIN. CT SCAN SHOWED A GIANT MACERATED HEMATOMA WHERE THE KIDNEY USED TO BE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIEMENS | LITHOSTAR | FFK | SIEMENS | 8799009 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| O |