SAE / AE Tracker
EU-MDR Article 87 safety event monitoring and countdown tracking
Open SAEs
2
Serious adverse events
Open AEs
2
Adverse events
Open Complaints
1
Device complaints
Overdue
2
Past regulatory deadline
Safety Event Register
| Event ID | Site | Type | Severity | Awareness | Deadline | Countdown | Status | Assigned |
|---|---|---|---|---|---|---|---|---|
| SAE-001 | 04 — Hamburg | SAE | serious | 02 Mar 2026 | 17 Mar 2026 | Day 74 of 15 | Open | USER-001 |
| SAE-002 | 07 — Lyon | COMPLAINT | complaint | 13 Mar 2026 | 28 Mar 2026 | Day 63 of 15 | Open | USER-001 |
| SAE-003 | 01 — Brussels | SAE | serious | 05 Oct 2025 | 20 Oct 2025 | Day 222 of 15 | Closed | USER-001 |
| SAE-004 | 03 — Barcelona | AE | non-serious | 12 Sep 2025 | 27 Sep 2025 | Day 245 of 15 | Closed | USER-001 |
| SAE-005 | 08 — Warsaw | AE | non-serious | 03 Dec 2025 | 18 Dec 2025 | Day 163 of 15 | Closed | USER-001 |