FDA Adverse Event
Malfunction
Summary report: N
MST TRABECTOME
MDR report key: 12322031
·
Received August 13, 2021
Report
- Report Number
- 3019924-2021-00002
- Event Type
- Malfunction
- Date Received
- August 13, 2021
- Date of Event
- June 24, 2021
- Report Date
- August 6, 2021
- Product Code
- HQR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE HANDPIECE WAS LEAKING SEEMS TO HAVE A HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216321 | MST TRABECTOME | APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED | HQR | 600018-04 | 124320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |