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
4.67
2019-02
0
2.34
2019-03
0
3.13
2019-04
0
3.17
2019-05
0
3.26
2019-06
0
2.82
2019-07
0
3.81
2019-08
0
3.49
2019-09
0
3.35
2019-10
0
3.19
2019-11
0
5.28
2019-12
0
5.45
2020-01
0
5.46
2020-02
0
4.5
2020-03
0
3.98
2020-04
0
5.42
2020-05
0
3.88
2020-06
0
3.71
2020-07
0
3.74
2020-08
0
4.23
2020-09
0
4.05
2020-10
0
4.53
2020-11
0
6.39
2020-12
0
5.41
2021-01
0
4.74
2021-02
0
3.95
2021-03
0
3.83
2021-04
0
3.82
2021-05
0
4.06
2021-06
0
4.11
2021-07
0
4
2021-08
0
4.46
2021-09
0
4.05
2021-10
0
4.44
2021-11
0
4.37
2021-12
0
4.43
2022-01
0
4
2022-02
0
3.37
2022-03
0
3.88
2022-04
0
3.8
2022-05
0
4.06
2022-06
0
3.85
2022-07
0
3.56
2022-08
0
4.39
2022-09
0
3.86
2022-10
0
4.15
2022-11
0
2.87
2022-12
0
3.93
2023-01
0
3.27
2023-02
1
3.2
2023-03
0
3.8
2023-04
0
4.26
2023-05
0
4.67
2023-06
0
4.2
2023-07
0
3.85
2023-08
0
4.49
2023-09
0
4.47
2023-10
0
4.71
2023-11
0
4.63
2023-12
0
5.49
2024-01
0
5.56
2024-02
0
4.93
2024-03
0
4.78
2024-04
0
5.43
2024-05
0
6.48
2024-06
0
7.52
2024-07
0
4.11
2024-08
0
4.21
2024-09
0
5
2024-10
0
4.7
2024-11
0
4.41
2024-12
0
4.25
2025-01
0
5.12
2025-02
0
4.81
2025-03
0
4.57
2025-04
0
4.98
2025-05
0
5.81
2025-06
0
5.47
2025-07
0
5.19
2025-08
0
5.08
2025-09
0
4.29
2025-10
0
4.62
2025-11
0
5.25
2025-12
0
6.07
2026-01
0
5.06
2026-02
0
5.39
2026-03
0
5.98
2026-04
0
5.93
2026-05
0
5.88
2026-06
0
6.16
This device (reports/month)Average device in MBI (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.