FDA Adverse Event
Injury
Summary report: N
INTRACORPORAL LITHOTRIPTOR
MDR report key: 1984028
·
Received February 4, 2011
Report
- Report Number
- 3004096429-2011-00001
- Event Type
- Injury
- Date Received
- February 4, 2011
- Report Date
- February 3, 2011
- Manufacturer
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- Product Code
- FFK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FOR THE TIME BEING, WE DON'T THINK THAT THERE IS ANY RELATIONSHIP BETWEEN THE DEVICE AND THE "BURNS MARKS" OBSERVED. NEVERTHELESS, WE WAIT THE RETURN OF THE DEVICE FOR DEEPER ANALYSIS.
Description of Event or Problem · 1
AFTER THE USE OF LITHOCLAST MASTER FOR PCNL SURGERY, THE PTS DEVELOP "BURN MARKS" ON THE STOMACH REGION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRACORPORAL LITHOTRIPTOR | SWISS LITHOCLAST MASTER DEVICE | FFK | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | FT-128 | OF-01-10351-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |