FDA Adverse Event
Malfunction
Summary report: N
IRRIGATION TRAY
MDR report key: 316997
·
Received February 15, 2001
Report
- Report Number
- 2429473-2001-00019
- Event Type
- Malfunction
- Date Received
- February 15, 2001
- Report Date
- February 15, 2001
- Manufacturer
- RUSCH INC.
- Product Code
- EYN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS THAT WHEN DRAINING THE IRRIGATION TRAY THE PLUNGER LEAKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5980 | IRRIGATION TRAY | UROLOGY | EYN | RUSCH INC. | NA | S0177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |