MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-03 for HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR M00202175208P0 manufactured by Intervascular Sas.
Report Number | 1640201-2019-00036 |
MDR Report Key | 8757537 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-07-03 |
Date of Report | 2019-08-08 |
Date of Event | 2019-06-13 |
Date Mfgr Received | 2019-07-17 |
Device Manufacturer Date | 2018-11-28 |
Date Added to Maude | 2019-07-03 |
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 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 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR |
Generic Name | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
Product Code | MAL |
Date Received | 2019-07-03 |
Returned To Mfg | 2019-07-08 |
Model Number | M00202175208P0 |
Catalog Number | M00202175208P0 |
Lot Number | 18L28 |
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 | 2019-07-03 |