MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-22 for BRACHY SOURCE IMPLANT SEED STM 1251 * manufactured by Bard Brachy Therapy, Inc..
[769694]
During transperineal implantation of iodine -125 seeds under transrectal ultrasound guidance, a 2 cm portion of the tip of the needle broke off in the right lateral portion of the prostate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 967127 |
| MDR Report Key | 967127 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-08-29 |
| Date of Event | 2006-08-25 |
| Date Facility Aware | 2006-08-25 |
| Report Date | 2006-08-29 |
| Date Reported to Mfgr | 2006-08-29 |
| Date Added to Maude | 2007-12-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRACHY SOURCE IMPLANT SEED |
| Generic Name | * |
| Product Code | IWJ |
| Date Received | 2006-09-22 |
| Model Number | STM 1251 |
| Catalog Number | * |
| Lot Number | 160364E36 |
| ID Number | 302039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 936780 |
| Manufacturer | BARD BRACHY THERAPY, INC. |
| Manufacturer Address | * CAROL STREAM IL 60188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-22 |