FDA Adverse Event
Other
Summary report: N
ULTRASONIC LITHOTRIPTOR
MDR report key: 26182
·
Received September 14, 1995
Report
- Report Number
- 2020550-1995-00035
- Event Type
- Other
- Date Received
- September 14, 1995
- Date of Event
- July 9, 1995
- Report Date
- September 12, 1995
- Manufacturer
- BLACKSTONE ULTRASONICS
- Product Code
- FEO
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS PREPPED AND ANESTHETIZED AND THE ULTRASONIC LITHOTRIPSY UNIT FAILED TO WORK. PT HAD TO BE RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRASONIC LITHOTRIPTOR | ULTRASONIC LITHOTRIPTOR | FEO | BLACKSTONE ULTRASONICS | 27086C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |