MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for C4D SOFTWARE CATALYST SP-002 manufactured by C-rad Positioning Ab.
| Report Number | 3006621300-2020-00001 |
| MDR Report Key | 9834353 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | BREDGRAND 18 |
| Manufacturer City | UPPSALA, UPPSALA 75320 |
| Manufacturer Country | SW |
| Manufacturer Postal | 75320 |
| Manufacturer G1 | C-RAD POSITIONING AB |
| Manufacturer Street | BREDGRAND 18 |
| Manufacturer City | UPPSALA, UPPSALA 75320 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 75320 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C4D SOFTWARE |
| Generic Name | SOFTWARE FOR RADIOTHERAPY POSITIONING SYSTEM |
| Product Code | IYE |
| Date Received | 2020-03-16 |
| Model Number | CATALYST |
| Catalog Number | SP-002 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C-RAD POSITIONING AB |
| Manufacturer Address | BREDGRAND 18 UPPSALA, UPPSALA 75320 SW 75320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |