MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-09 for INSTANT LINK MAGAZINE manufactured by Theragenics.
[1577766]
Instant link seed cartridge had a product defect that did not allow all of the seeds to be released from the cartridge for implantation. This resulted in increased operating room time and anesthetic. Seed implantation, discovery of problem and information provided (b) (6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015517 |
| MDR Report Key | 1658752 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-04-09 |
| Date of Event | 2010-03-23 |
| Date Added to Maude | 2010-04-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSTANT LINK MAGAZINE |
| Generic Name | PROSTATE SEED IMPLANT CARTRIDGE |
| Product Code | IWG |
| Date Received | 2010-04-09 |
| Returned To Mfg | 2010-03-23 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAGENICS |
| Manufacturer Address | BUFORD GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-09 |