MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-02-15 for ARTEGRAFT AG740 manufactured by Artegraft, Inc..
[136327516]
Mw5082732. The report indicates that the artegraft product was not accessed following the artegraft, inc. Instructions for use (ifu). The ifu states that "a minimum of ten days should be allowed after implantation before puncturing the graft with needles for hemodialysis. " the medwatch report states that the graft was accessed the day after the procedure. Patient information, lot /batch number, and details of the issue/event were not provided. No contact information and no hospital information were provided, therefore, artegraft, inc. Is not able to request follow-up information related to the event. A specific root cause was not able to be identified.
Patient Sequence No: 1, Text Type: N, H10
[136327517]
Artegraft, inc. Received medwatch report mw5082732. The report states "accessed graft the day after my procedure and had severe bleeding and then developed an infection. Spoke with sensor sales person and said that it was acceptable to access next day and there is no evidence of previous infections".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2019-00001 |
| MDR Report Key | 8345087 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-01-28 |
| Date Added to Maude | 2019-02-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CYNTHIA SALTER |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal | 089024247 |
| Manufacturer Phone | 7324228333 |
| Manufacturer G1 | ARTEGRAFT, INC. |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 089024247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEGRAFT |
| Generic Name | COLLAGEN VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2019-02-15 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT, INC. |
| Manufacturer Address | 206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-15 |