AFX Adverse Event — Injury (MDR 2031527-2020-00142)
AFX Adverse Event — Injury (MDR 2031527-2020-00142) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AFX; Generic name: VELA SUPRARENAL; Manufacturer: ENDOLOGIX.
| Device | AFX |
|---|---|
| Generic name | VELA SUPRARENAL |
| Manufacturer | ENDOLOGIX |
| Report number | 2031527-2020-00142 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPLY. |
| Source | openFDA MAUDE (device adverse events) |
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