MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-18 for HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR M002020851270 manufactured by Intervascular Sas.
[133857739]
It was reported that the product is available for investigation, it should be returned to intervascular for content examination. The graft corresponding to the product box labeling was manufactured on august 2015 by intervascular (b)(4) in (b)(6), it was delivered to the consignment stock at (b)(6) hospital on (b)(6) 2016. The graft that was found inside the product box was manufactured by maquet cardiovascular llc in the united states and was delivered to the consignment stock at (b)(6) hospital on (b)(6) 2014. Therefore, it is assumed that the packaging transfer occurred during storage at the consignment stock. The investigation is still ongoing. A follow up report will be sent upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133857740]
Staff opened the box and noticed that the graft inside did not match the box labeling. They thought they were opening a graft whose dimensions were 12mmx7mmx40cm, instead they found a graft whose dimensions were 14mmx7mmx40cm. A replacement device was used to complete the procedure. No patient was involved. It was reported that the event occurred some time ago but there was a reporting omission. The event date is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00005 |
| MDR Report Key | 8260461 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-18 |
| Date of Report | 2019-04-08 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2019-01-18 |
| 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 GOLD KNITTED MICROVEL DOUBLE VELOUR |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | MAL |
| Date Received | 2019-01-18 |
| Model Number | M002020851270 |
| Catalog Number | M002020851270 |
| Lot Number | 15H26 |
| 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 | 2019-01-18 |