MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-05 for AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 CC286297 manufactured by Cellavision Ab.
| Report Number | 3003630693-2019-00002 |
| MDR Report Key | 8669611 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-05 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-03-23 |
| Date Added to Maude | 2019-06-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MAGNUS JOHNSSON |
| Manufacturer Street | MOBILV |
| Manufacturer City | LUND, 22362 |
| Manufacturer Country | SW |
| Manufacturer Postal | 22362 |
| Manufacturer G1 | CELLAVISION AB |
| Manufacturer Street | MOBILV |
| Manufacturer City | LUND, 22362 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 22362 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 |
| Generic Name | AUTOMATED CELL-LOCATING DEVICE |
| Product Code | JOY |
| Date Received | 2019-06-05 |
| Model Number | DI-60 |
| Catalog Number | CC286297 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLAVISION AB |
| Manufacturer Address | MOBILV?GEN 12 LUND, 223 62 SW 223 62 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-05 |