MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-09 for HEMASHIELD PLATINUM M00202175210P0 manufactured by Intervascular Sas.
[99800985]
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. The investigation is still ongoing. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[99800986]
The hospital reported that during preparation for a case, a (b)(4) hemashield platinum woven box was opened. The box was intact and was properly labeled and had the plastic tray inside the box but no graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2018-00005 |
| MDR Report Key | 7258601 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-09 |
| Date of Report | 2018-03-06 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2018-02-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2018-02-09 |
| Returned To Mfg | 2018-02-19 |
| Model Number | M00202175210P0 |
| Catalog Number | M00202175210P0 |
| Lot Number | 17H02 |
| 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 | Z.I. ATHELIA I LA CIOTAT CEDEX, 13705 FR 13705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |