AFX Adverse Event — Injury (MDR 2031527-2020-00143)
AFX Adverse Event — Injury (MDR 2031527-2020-00143) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AFX; Generic name: BIFURCATED STENT GRAFT; Manufacturer: ENDOLOGIX.
| Device | AFX |
|---|---|
| Generic name | BIFURCATED STENT GRAFT |
| Manufacturer | ENDOLOGIX |
| Report number | 2031527-2020-00143 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | CLINICAL ASSESSMENT OF THE REPORTED EVENT WAS UNABLE TO BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. REQUESTS WERE MADE; HOWEVER, DENIED DUE TO REQUIREMENTS FOR PATIENT AUTHORIZATION. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE ASSESSED. ALSO, A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL A |
| Source | openFDA MAUDE (device adverse events) |
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