FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2018770
·
Received February 28, 2011
Report
- Report Number
- 9613347-2011-00007
- Event Type
- Other
- Date Received
- February 28, 2011
- Date of Event
- January 17, 2011
- Report Date
- February 25, 2011
- Manufacturer
- STORZ MEDICAL AG
- Product Code
- LNS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HEMATOMA IS A KNOWN SIDE EFFECT OF ESWL LITHOTRIPSY TREATMENT AND IS ADDRESSED IN OUR LABELING. THERE WAS NO REPORT OF DEVICE MALFUNCTION. A SERVICE EVAL WAS PERFORMED AFTER THE PROCEDURE AND UNIT WAS FOUND TO BE FUNCTIONING PROPERLY.
Description of Event or Problem · 1
ALLEGEDLY, THREE DAYS POST THE LITHOTRIPSY PROCEDURE, THE PT WAS ADMITTED FOR HEMATOMA. HE WAS TRANSFUSED WITH 2 UNITS OF BLOOD, STABILIZED AND DISCHARGED AFTER ONE DAY. PT IS RECOVERING WITHOUT FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | MODULITH SLX | LNS | STORZ MEDICAL AG | 12400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization |