MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-07 for MC3 5671 manufactured by Mc3 Inc..
| Report Number | 3011468686-2019-00002 |
| MDR Report Key | 9560425 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-07-31 |
| Date Added to Maude | 2020-01-07 |
| 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 | MS. MARTHA RUMFORD |
| Manufacturer Street | 2555 BISHOP CIRCLE WEST |
| Manufacturer City | DEXTER MI 48130 |
| Manufacturer Country | US |
| Manufacturer Postal | 48130 |
| Manufacturer Phone | 7349959089 |
| Manufacturer G1 | MC3 INC. |
| Manufacturer Street | 2555 BISHOP CIRCLE WEST |
| Manufacturer City | DEXTER MI 48130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MC3 |
| Generic Name | CARDIOVASCULAR CANNULA |
| Product Code | DWF |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2019-12-09 |
| Model Number | 5671 |
| Catalog Number | 5671 |
| Lot Number | 1907129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MC3 INC. |
| Manufacturer Address | 2555 BISHOP CIRCLE WEST DEXTER MI 48130 US 48130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |