MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for BRACHYSOURCE? MODEL STM1251 I-125 BRACHYTHERAPY SEED manufactured by Bard Brachytherapy, Inc. -1424526.
[128434034]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[128434035]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-05635 |
| MDR Report Key | 8103054 |
| Date Received | 2018-11-26 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2019-01-27 |
| Date Added to Maude | 2018-11-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Street | 295 EAST LIES ROAD |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BRACHYSOURCE? MODEL STM1251 I-125 BRACHYTHERAPY SEED |
| Generic Name | BRACHYSOURCE |
| Product Code | KXK |
| Date Received | 2018-11-26 |
| Catalog Number | STM1251 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Address | 295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-26 |