FDA Adverse Event
Injury
Summary report: N
ALFAPUMP SYSTEM
MDR report key: 23627659
·
Received November 23, 2025
Report
- Report Number
- 3010817031-2025-00002
- Event Type
- Injury
- Date Received
- November 23, 2025
- Date of Event
- October 23, 2025
- Report Date
- November 23, 2025
- Manufacturer
- SEQUANA MEDICAL NV
- Product Code
- SDQ
- PMA / PMN Number
- P230044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
OUTSIDE US CASE, BECAUSE IN CANADA: PATIENT REPORTED THAT THE BLADDER CATHETER HAS ERODED THROUGH THE SKIN AND WAS EXPOSED. PATIENT WAS HOSPITALIZED AND REMOVAL OF THE BLADDER CATHETER SCHEDULED. THE DISTAL PART OF THE BLADDER CATHETER WAS REMOVED, LEFT APPROXIMATELY 5CM OF THE BLADDER CATHETER ATTACHED TO THE PUMP AND TIED IT CLOSED. NO NEW PARTS WERE INSERTED AS PART OF THIS RE-INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2489555 | ALFAPUMP SYSTEM | ALFAPUMP SYSTEM | SDQ | SEQUANA MEDICAL NV | BLADDER CATHETER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |