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 reportMalfunction 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
1.5
2019-02
0
2.25
2019-03
0
1.83
2019-04
0
2.78
2019-05
0
1.17
2019-06
0
2.33
2019-07
0
1.6
2019-08
0
1.86
2019-09
0
2.43
2019-10
0
1.2
2019-11
0
1.75
2019-12
0
1.6
2020-01
0
5
2020-02
0
3.18
2020-03
0
3.6
2020-04
0
1.38
2020-05
0
1.4
2020-06
0
3.69
2020-07
0
1.45
2020-08
0
1.29
2020-09
0
1.79
2020-10
0
1.88
2020-11
0
1.62
2020-12
0
2.14
2021-01
0
1.87
2021-02
0
2.71
2021-03
0
2.17
2021-04
0
1.8
2021-05
0
1.83
2021-06
0
2.27
2021-07
0
10.32
2021-08
0
3.17
2021-09
0
2
2021-10
0
2.36
2021-11
0
1.33
2021-12
0
1.92
2022-01
0
1
2022-02
0
1
2022-03
0
2
2022-04
0
1.64
2022-05
0
1.5
2022-06
0
2.64
2022-07
0
1.68
2022-08
0
3.67
2022-09
0
3.86
2022-10
0
1.73
2022-11
0
2.75
2022-12
0
2.22
2023-01
0
3.25
2023-02
0
3.4
2023-03
0
3.86
2023-04
0
2.33
2023-05
0
7.25
2023-06
0
1.25
2023-07
0
2
2023-08
0
1.92
2023-09
0
3
2023-10
0
1.33
2023-11
0
1.73
2023-12
0
1.31
2024-01
0
2.17
2024-02
0
1
2024-03
0
3.1
2024-04
0
1.43
2024-05
0
2
2024-06
0
2.08
2024-07
0
2.36
2024-08
0
2.1
2024-09
0
1.69
2024-10
0
3
2024-11
0
1.5
2024-12
0
1.92
2025-01
0
3.8
2025-02
0
1.8
2025-03
1
1.47
2025-04
0
1.38
2025-05
0
1.5
2025-06
0
5.33
2025-07
0
2.23
2025-08
0
1.7
2025-09
0
2
2025-10
0
2.18
2025-11
0
2.1
2025-12
0
2.5
2026-01
0
3.43
2026-02
0
2.67
2026-03
0
3.14
2026-04
0
1.69
2026-05
0
3
2026-06
0
2.55
This device (reports/month)Average device in NKG (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
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.