MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for TACK ENDOVASCULAR SYSTEM? (6F, 3.5-6.0MM) 156135061 manufactured by Intact Vascular.
| Report Number | 3012608866-2020-00001 |
| MDR Report Key | 9898387 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-03-30 |
| 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. JOSEPH GRIFFIN III |
| Manufacturer Street | 1285 DRUMMERS LANE SUITE 200 |
| Manufacturer City | WAYNE, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 2531048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TACK ENDOVASCULAR SYSTEM? (6F, 3.5-6.0MM) |
| Generic Name | SCAFFOLD, DISSECTION REPAIR |
| Product Code | QCT |
| Date Received | 2020-03-30 |
| Catalog Number | 156135061 |
| Lot Number | 206193 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTACT VASCULAR |
| Manufacturer Address | 1285 DRUMMERS LANE SUITE 200 WAYNE, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |