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 |