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 |