MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-23 for CRESCENT JUGULAR DUAL LUMEN CATHETER 70132 manufactured by Mc3 Incorporated.
| Report Number | 3011468686-2019-00001 |
| MDR Report Key | 8818533 |
| Date Received | 2019-07-23 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-07-23 |
| 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 | ADAM VIITALA |
| Manufacturer Street | 2555 BISHOP CIRCLE W |
| Manufacturer City | DEXTER 48130 |
| Manufacturer Country | US |
| Manufacturer Postal | 48130 |
| Manufacturer Phone | 7349959089 |
| Manufacturer G1 | MC3 INCORPORATED |
| Manufacturer Street | 2555 BISHOP CIRCLE W |
| 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 | 0 |
| Brand Name | CRESCENT JUGULAR DUAL LUMEN CATHETER |
| Generic Name | DUAL LUMEN ECMO CANNULA |
| Product Code | PZS |
| Date Received | 2019-07-23 |
| Catalog Number | 70132 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MC3 INCORPORATED |
| Manufacturer Address | 2555 BISHOP CIRCLE W DEXTER MI 48130 US 48130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-23 |