MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-03 for AUTOMATED DIGITAL CELL MORPHOLGY ANALYSER DI-60 CC286297 manufactured by Cellavision Ab.
| Report Number | 3003630693-2019-00001 |
| MDR Report Key | 8662546 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-03 |
| Date of Report | 2019-05-27 |
| Date of Event | 2019-04-25 |
| Date Added to Maude | 2019-06-03 |
| 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 | MR. MAGNUS JOHNSSON |
| Manufacturer Street | MOBILV |
| Manufacturer City | LUND, SE-223 62 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-223 62 |
| Manufacturer G1 | CELLAVISION AB |
| Manufacturer Street | MOBILV |
| Manufacturer City | LUND, SE-223 62 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-223 62 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATED DIGITAL CELL MORPHOLGY ANALYSER DI-60 |
| Generic Name | DI-60 |
| Product Code | JOY |
| Date Received | 2019-06-03 |
| Model Number | DI-60 |
| Catalog Number | CC286297 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLAVISION AB |
| Manufacturer Address | MOBILV?GEN 12 LUND, SE-223 62 SW SE-223 62 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-03 |