MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-02 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175926P0 manufactured by Intervascular Sas.
[122328675]
Patient Sequence No: 1, Text Type: N, H10
[122328676]
During surgery for aneurysmal disease, the graft had a serious hole bleeding problem. There was no transfusion during the surgery. Surgeon used drugs as bioglue to stop bleeding. The patient remained implanted and stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00020 |
| MDR Report Key | 7925828 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-02 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-11-19 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2018-10-02 |
| 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 | MRS. LAURE FRAYSSE |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal | 13705 |
| Manufacturer G1 | INTERVASCULAR SAS |
| Manufacturer Street | Z.I. ATHELIA I |
| Manufacturer City | LA CIOTAT CEDEX, 13705 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 13705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-10-02 |
| Model Number | M00202175926P0 |
| Catalog Number | M00202175926P0 |
| Lot Number | 18E23 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVASCULAR SAS |
| Manufacturer Address | Z.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-02 |