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 2019-03-01 for HEMASHIELD PLATINUM FINESSE ULTRA-THIN KNITTED M00202019579P0 manufactured by Intervascular Sas.
[139341529]
It was reported that the product is available for investigation, it should be returned to intervascular for examination. A review of the complaint device history records, indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests including a 100% visual inspection of the patch. Specifically, no anomaly was evidenced in the collagen coating records. A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified. A visual inspection by the qa department will be performed. The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number. 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
[139341530]
The event occurred during preparation for a procedure. Upon opening the package, the patch was found to have a "sticky brown gunk" down the midline. There was enough of it to contaminate the tech's gloves from touching the patch. A replacement device was used to complete the procedure. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1640201-2019-00015 |
| MDR Report Key | 8383489 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-01 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2018-09-26 |
| Date Added to Maude | 2019-03-01 |
| 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 FINESSE ULTRA-THIN KNITTED |
| Generic Name | VASCULAR POLYESTER GRAFT |
| Product Code | DXZ |
| Date Received | 2019-03-01 |
| Model Number | M00202019579P0 |
| Catalog Number | M00202019579P0 |
| Lot Number | 18J26 |
| Device Availability | Y |
| 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 | 2019-03-01 |