N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
MAUDE MDR 8298026
- MDR report key
- 8298026
- Report number
- 1018233-2019-00560
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-11
- Date received
- 2019-02-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- YONIC ANDERSON
- Address
- 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN READYLINK? | SOURE LINK | BARD BRACHYTHERAPY, INC. -1424526 | KNX | STM1251RL | 11663063 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-01 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS A WHITE FOREIGN MATERIAL FOUND ON THE TRAY.