D
Patient 1
IT WAS REPORTED UPON OPENING PACKAGE A HOLE WAS NOTED IN THE POUCH CONTAINING THE MICK CONTAINER COMPROMISING THE STERILE BARRIER.
MAUDE MDR 3960623
- MDR report key
- 3960623
- Report number
- 1018233-2014-00156
- Event key
- 0
- Event type
- 3
- Date received
- 2014-06-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHRISTY LEWIS
- 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 | BRACHYSOURCE IODINE - 125 SEEDS IN MICK CARTRIDGE | BARD BRACHYTHERAPY, INC. | KXK | NA | PS1251CS | 3BYE0028/BBYE0052 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-20 | 0 |
Event Narratives#
N
Patient 1
INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.