MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for GRAFT AG740 manufactured by Artegraft, Inc..
[131981442]
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 | MW5082732 |
| MDR Report Key | 8208545 |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-12 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GRAFT |
| Generic Name | TISSUE GRAFT OF 6MM AND GREATER |
| Product Code | LXA |
| Date Received | 2018-12-27 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT, INC. |
| Manufacturer Address | 206 NORTH CENTER DR NORTH BRUNSWICK NJ 08902 US 08902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-27 |