MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for HEMASHIELD PLATINUM DOUBLE VELOUR M00202175210P0 manufactured by Intervascular Sas.
Report Number | 2242352-2019-01136 |
MDR Report Key | 9205419 |
Date Received | 2019-10-17 |
Date of Event | 2019-09-13 |
Date Facility Aware | 2019-09-18 |
Report Date | 2019-10-17 |
Date Reported to FDA | 2019-10-17 |
Date Reported to Mfgr | 2019-10-17 |
Date Added to Maude | 2019-10-17 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HEMASHIELD PLATINUM DOUBLE VELOUR |
Generic Name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
Product Code | MAL |
Date Received | 2019-10-17 |
Model Number | M00202175210P0 |
Catalog Number | M00202175210P0 |
Lot Number | 19F05 |
Device Availability | N |
Device Age | 1 DA |
Device Eval'ed by Mfgr | * |
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 | 1. Required No Informationntervention | 2019-10-17 |