D
Patient 1
(B)(4). THE MANUFACTURER IDENTIFIED THAT THE CUSTOMER ORDER WAS PROCESSED AND SHIPPED WITH THE INCORRECT ACTIVITY OF IODINE SEEDS. THE CUSTOMER WAS CONTACTED PRIOR TO USE.
MAUDE MDR 3192256
- MDR report key
- 3192256
- Report number
- 1018233-2013-02519
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-05-21
- Date received
- 2013-06-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KIM SHIRAH
- 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 I-125 IMPLANT, LOOSE, STERILE | BARD BRACHYTHERAPY, INC. | KXK | NA | PS-1251LS | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-06-20 | 0 |
Event Narratives#
N
Patient 1
THE INVESTIGATION REMAINS IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.