FDA Adverse Event
Malfunction
Summary report: N
VITREQ
MDR report key: 16119019
·
Received January 8, 2023
Report
- Report Number
- 3012037425-2023-00001
- Event Type
- Malfunction
- Date Received
- January 8, 2023
- Date of Event
- December 1, 2022
- Report Date
- January 6, 2023
- Manufacturer
- VITREQ BV
- Product Code
- JOS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
POST SURGERY THE CT00.D01 - VITREQ, CRYO TREQ PROBE BX/3 DEVICE WAS DISCARDED IN THE TRASH CAN WITHOUT THE GAS FROM THE DEVICE BEING RELEASED, THE DEVICE " CAME APART" IN THE TRASH CAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2307024 | VITREQ | CRYOTREQ | JOS | VITREQ BV | 20229334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |