MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-06 for PROXCELAN MODEL CS-1 N/A manufactured by Isoray Medical, Inc. / Shannon Goldenstein.
| Report Number | 3005520039-2019-00001 |
| MDR Report Key | 9284730 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-06 |
| Date of Report | 2019-10-24 |
| Date Mfgr Received | 2019-09-27 |
| Device Manufacturer Date | 2019-08-29 |
| Date Added to Maude | 2019-11-06 |
| 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 | MRS. SHANNON GOLDENSTEIN |
| Manufacturer Street | 350 HILLS STREET., SUITE., 106 |
| Manufacturer City | RICHLAND WA 99354 |
| Manufacturer Country | US |
| Manufacturer Postal | 99354 |
| Manufacturer Phone | 5093751202 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROXCELAN MODEL CS-1 |
| Generic Name | CS-1 CESIUM-131 BRACHYTHERAPY SEEDS |
| Product Code | KXK |
| Date Received | 2019-11-06 |
| Model Number | CS-1 |
| Catalog Number | N/A |
| Lot Number | DO1935-021 |
| Device Expiration Date | 2019-09-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISORAY MEDICAL, INC. / SHANNON GOLDENSTEIN |
| Manufacturer Address | 350 HILLS STREET, STE., 106 RICHLAND, WA WA 99354 US 99354 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-06 |