LOTUS EDGE VALVE Adverse Event — Injury (MDR 2134265-2020-05222)
LOTUS EDGE VALVE Adverse Event — Injury (MDR 2134265-2020-05222) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LOTUS EDGE VALVE; Generic name: LOTUS EDGE TM VALVE SYSTEM; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | LOTUS EDGE VALVE |
|---|---|
| Generic name | LOTUS EDGE TM VALVE SYSTEM |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05222 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | STUDY |
| Narrative | EXEMPTION NUMBER: E2020001. QUARTERLY REPORTING PERIOD: Q1 2020. AVERAGE TIME TO EVENT: 5 DAYS. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE POTENTIAL ADVERSE |
| Source | openFDA MAUDE (device adverse events) |
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