FDA Adverse Event
Injury
Summary report: N
OPTILUME BPH CATHETER SYSTEM
MDR report key: 20164166
·
Received September 6, 2024
Report
- Report Number
- 3015228875-2024-00003
- Event Type
- Injury
- Date Received
- September 6, 2024
- Date of Event
- August 6, 2024
- Report Date
- September 6, 2024
- Manufacturer
- UROTRONIC INC.
- Product Code
- QXB
- PMA / PMN Number
- P220029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ANY REQUIRED FIELDS THAT ARE BLANK ARE DUE TO INFORMATION THAT IS CURRENTLY UNKNOWN OR UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
ON AUGUST 6, 2024, UROTRONIC WAS MADE AWARE OF A PATIENT TREATED WITH BPH CATHETER SYSTEM ON (B)(6) 2024. THE PATIENT COMPLAINED TO THE TREATING PHYSICIAN OF BLEEDING/HEMATURIA DURING RECOVERY. BETWEEN (B)(6) 2024, THE PHYSICIAN DECIDED TO BRING THE PATIENT TO THE OR FOR CLOT EVACUATION AND FULGURATION. NO PERMANENT SEQUELAE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1302591 | OPTILUME BPH CATHETER SYSTEM | BPH CATHETER SYSTEM | QXB | UROTRONIC INC. | 1189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |