N
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
MAUDE MDR 8103054
- MDR report key
- 8103054
- Report number
- 1018233-2018-05635
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-02
- Date received
- 2018-11-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- 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 | BRACHYSOURCE? MODEL STM1251 I-125 BRACHYTHERAPY SEED | BRACHYSOURCE | BARD BRACHYTHERAPY, INC. -1424526 | KXK | STM1251 | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-26 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE SEED ACTIVITY STATED ON THE TWO IMPLANT CERTIFICATES DID NOT CORRESPOND. THE 10% ASSAY CERTIFICATE STATED 0.449MCI MID POINT COMPARED TO 0.460MCI FOR THE GROUP CERTIFICATE. THE ISSUE WAS INVESTIGATED AND THE CUSTOMER USED THE 0.449MCI VALUE. PER ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 16-NOV-2018, & PER HER CONVERSATION WITH DR. (B)(6), HE ORDERED .449 MC AND THE RANGE MIDPOINT ON IMPLANT DATES STATES .414 MC. THERE WAS A DIFFERENCE IN HIS OWN RESOLUTION PLANNING, THE DOCTOR COULD NOT FULLY CONFIRM IF IT WAS THE CORRECT DOSAGE. HE WANTED CLARIFICATION IF HE MISINTERPRETED THE CERTIFICATE. PER ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 22-NOV-2018, THE ORIGINAL ORDER WAS FOR 0.46MCI. THE ASSAY CERTIFICATE SHOWED 0.449 MID POINT VALUE.