MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-06 for HEMASHIELD PLATINUM M00202175132P0 manufactured by Intervascular Sas.
[99316039]
((b)(4)) a review of the complaint device history records indicated that the graft was processed and inspected according to established tests and procedures and no anomaly was found. ((b)(4)) no conclusion can be drawn. The investigation performed would tend to indicate that the product was not defective at the time of manufacturing. However, a non conformance report has been initiated in order to further investigate the root cause of the event and take appropriate corrective action if necessary.
Patient Sequence No: 1, Text Type: N, H10
[99316040]
It was reported by the hospital two cases were the devices were found with no label for documentation and no direction for use in the packaging. The devices were used without any consequence for patients. The second case is submitted under manufacturer report number 1640201-2018-00003.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00004 |
| MDR Report Key | 7243513 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-06 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2018-02-06 |
| 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 | ZI ATHELIA 1 |
| 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 |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-02-06 |
| Model Number | M00202175132P0 |
| Catalog Number | M00202175132P0 |
| Lot Number | 17C29 |
| Device Availability | N |
| 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 | 2018-02-06 |