Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportDeath 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.64
2019-02
0
3.27
2019-03
0
2.21
2019-04
0
2.4
2019-05
0
2.18
2019-06
0
3.28
2019-07
0
3.95
2019-08
0
3.9
2019-09
0
2.53
2019-10
0
3.61
2019-11
0
3.11
2019-12
0
3.55
2020-01
0
3.91
2020-02
0
5.88
2020-03
0
3.63
2020-04
0
3.42
2020-05
0
4.13
2020-06
0
3.5
2020-07
0
3.28
2020-08
0
3.71
2020-09
0
3.21
2020-10
0
3.89
2020-11
0
4.39
2020-12
0
4.48
2021-01
0
3.62
2021-02
0
3.65
2021-03
0
3
2021-04
0
3.29
2021-05
0
3.35
2021-06
0
2.53
2021-07
0
2.68
2021-08
0
3.19
2021-09
0
4
2021-10
0
4
2021-11
0
4.62
2021-12
0
4.36
2022-01
0
4.08
2022-02
0
5.7
2022-03
0
4.5
2022-04
0
2.69
2022-05
0
2.38
2022-06
0
3.81
2022-07
0
3.17
2022-08
0
1.84
2022-09
0
2.82
2022-10
0
3.67
2022-11
0
1.77
2022-12
0
3.07
2023-01
0
2.73
2023-02
0
2.82
2023-03
0
2.85
2023-04
0
2.62
2023-05
0
2.88
2023-06
0
3.52
2023-07
0
2.31
2023-08
0
3.3
2023-09
0
2.5
2023-10
0
3.17
2023-11
0
3.07
2023-12
0
2.79
2024-01
0
2.65
2024-02
0
3.08
2024-03
0
2.45
2024-04
0
3.24
2024-05
0
2.7
2024-06
0
1.73
2024-07
0
2.53
2024-08
0
3.2
2024-09
0
2.36
2024-10
0
2.81
2024-11
0
2.44
2024-12
0
2.55
2025-01
0
1.89
2025-02
0
2.82
2025-03
0
1.65
2025-04
0
3.24
2025-05
0
2
2025-06
0
2.68
2025-07
0
2.21
2025-08
1
1.5
2025-09
0
1.88
2025-10
0
2.43
2025-11
0
1.6
2025-12
0
2.35
2026-01
0
1.94
2026-02
0
2
2026-03
0
1.76
2026-04
0
4.18
2026-05
0
3.5
2026-06
0
2.58
This device (reports/month)Average device in NRY (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2025-08-06
3014644549-2025-00001
Death
Available
exact di
Regulatory clearances
510(k)K240917Substantially equivalent (SESE) · 2024-10-01clearance family
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.