SES SMART CONTROL 7X80 120 Adverse Event — Malfunction (MDR 9616099-2020-03678)
SES SMART CONTROL 7X80 120 Adverse Event — Malfunction (MDR 9616099-2020-03678) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SES SMART CONTROL 7X80 120; Generic name: STENT, ILIAC; Manufacturer: CORDIS CORPORATION.
| Device | SES SMART CONTROL 7X80 120 |
|---|---|
| Generic name | STENT, ILIAC |
| Manufacturer | CORDIS CORPORATION |
| Report number | 9616099-2020-03678 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | CONCOMITANT MEDICAL PRODUCTS: SHEATH INTRODUCER 6F AVANTI+, GUIDING CATHETER 4F VER TEMPOM AQUA. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UP |
| Source | openFDA MAUDE (device adverse events) |
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