FDA Adverse Event
Malfunction
Summary report: N
MALE URINAL URI-MAX
MDR report key: 22792231
·
Received August 13, 2025
Report
- Report Number
- 22792231
- Event Type
- Malfunction
- Date Received
- August 13, 2025
- Date of Event
- June 2, 2025
- Report Date
- July 24, 2025
- Manufacturer
- GMAX INDUSTRIES INC
- Product Code
- FNP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
NOTICED IN THE PAST WEEK AND TONIGHT THAT URINE HAS BEEN LEAKING OUT FROM THE BOTTOM OF SOME OF THE URINALS, CAUSING WASTE TO GET ALL OVER COMPUTERS, LINENS, BEDSIDE TABLES, ETC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75920 | MALE URINAL URI-MAX | URINAL | FNP | GMAX INDUSTRIES INC | GP300 | 12758/138137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male |