FDA Adverse Event
Malfunction
Summary report: N
URINARY CATHETER
MDR report key: 23683352
·
Received December 1, 2025
Report
- Report Number
- MW5179637
- Event Type
- Malfunction
- Date Received
- December 1, 2025
- Report Date
- November 25, 2025
- Manufacturer
- INTEGRAL MEDICAL PRODUCTS CO., LTD
- Product Code
- GBM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
INFECTION OCCURRING DURING THE USE OF URINARY CATHETERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2849559 | URINARY CATHETER | CATHETER, URETHRAL | GBM | INTEGRAL MEDICAL PRODUCTS CO., LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |