MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for AFX2 BEA28-100/I20-40 manufactured by Endologix.
| Report Number | 2031527-2020-00122 |
| MDR Report Key | 9908792 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. EMILE PINSONNEAULT |
| Manufacturer Street | 3910 BRICKWAY BLVD , |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal | 95403 |
| Manufacturer Phone | 8009832284 |
| Manufacturer G1 | ENDOLOGIX SANTA ROSA |
| Manufacturer Street | 3910 BRICKWAY BLVD , |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFX2 |
| Generic Name | BIFURCATED STENT GRAFT |
| Product Code | MIH |
| Date Received | 2020-03-31 |
| Model Number | BEA28-100/I20-40 |
| Lot Number | 1354807-002 |
| Device Expiration Date | 2017-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOLOGIX |
| Manufacturer Address | 2 MUSICK , IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |