FDA Adverse Event
Malfunction
Summary report: N
VISICOIL FIDUCIAL
MDR report key: 21201000
·
Received January 21, 2025
Report
- Report Number
- MW5165003
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- October 10, 2024
- Report Date
- January 15, 2025
- Manufacturer
- IZI MEDICAL PRODUCTS LLC
- Product Code
- KXK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
WHEN INSERTING THE VISICOIL FIDUCIAL THE TIP OF THE IMPLANT BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 842164 | VISICOIL FIDUCIAL | SOURCE, BRACHYTHERAPY, RADIONUCLIDE | KXK | IZI MEDICAL PRODUCTS LLC | 23031523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male |