MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-07 for NAMIC 70055003 manufactured by Navilyst Medical, Inc..
| Report Number | 9289671 |
| MDR Report Key | 9289671 |
| Date Received | 2019-11-07 |
| Date of Report | 2019-10-11 |
| Date of Event | 2019-07-18 |
| Report Date | 2019-10-11 |
| Date Reported to FDA | 2019-10-11 |
| Date Reported to Mfgr | 2019-11-07 |
| Date Added to Maude | 2019-11-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAMIC |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2019-11-07 |
| Returned To Mfg | 2019-10-11 |
| Catalog Number | 70055003 |
| Lot Number | 5425318 |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL, INC. |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-07 |