MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-02 for HEMACAROTID KNITTED ULTRATHIN PATCH HEK08/75CPUT (1) manufactured by Intervascular Sas.
| Report Number | 1640201-2020-00006 |
| MDR Report Key | 9775441 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-02 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-24 |
| Date Added to Maude | 2020-03-02 |
| 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 | MS. FRANCOISE GAUDUCHON |
| Manufacturer Street | ZONE INDUSTRIELLE ATHELIA I |
| Manufacturer City | LA CIOTAT |
| Manufacturer Country | US |
| Manufacturer G1 | INTERVASCULAR SAS |
| Manufacturer Street | ZONE INDUSTRIELLE ATHELIA I |
| Manufacturer City | LA CIOTAT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMACAROTID KNITTED ULTRATHIN PATCH |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-03-09 |
| Model Number | HEK08/75CPUT (1) |
| Catalog Number | HEK08/75CPUT (1) |
| Lot Number | 19K24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | ZONE INDUSTRIELLE ATHELIA I LA CIOTAT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |