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.
2 linked reportsMalfunction 2
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
2.39
2019-02
0
2.93
2019-03
0
2.73
2019-04
0
2.39
2019-05
0
2.7
2019-06
0
2.44
2019-07
0
2.61
2019-08
0
2.51
2019-09
0
2.49
2019-10
0
3.33
2019-11
0
4.32
2019-12
0
2.92
2020-01
0
2.96
2020-02
0
3.99
2020-03
0
3.58
2020-04
0
6.2
2020-05
0
2.04
2020-06
0
2.89
2020-07
0
3.24
2020-08
0
2.31
2020-09
0
3.44
2020-10
0
4.41
2020-11
0
4.59
2020-12
0
3.72
2021-01
0
3.93
2021-02
0
3.43
2021-03
0
3.22
2021-04
0
3.18
2021-05
0
3.53
2021-06
0
3.32
2021-07
0
2.88
2021-08
0
2.72
2021-09
0
2.43
2021-10
0
2.23
2021-11
0
3.2
2021-12
0
2.66
2022-01
0
2.75
2022-02
0
2.99
2022-03
0
2.63
2022-04
0
2.28
2022-05
0
3.33
2022-06
0
3.42
2022-07
0
2.89
2022-08
0
2.53
2022-09
0
2.14
2022-10
0
3.18
2022-11
0
2.9
2022-12
0
3.31
2023-01
0
2.91
2023-02
0
2.84
2023-03
0
3.1
2023-04
0
2.59
2023-05
0
2.71
2023-06
0
2.37
2023-07
0
2.49
2023-08
0
2.19
2023-09
0
3.31
2023-10
0
2.85
2023-11
0
9.48
2023-12
0
3.98
2024-01
0
2.83
2024-02
0
3.54
2024-03
0
3.25
2024-04
0
3.17
2024-05
0
4.01
2024-06
0
3.67
2024-07
0
3.3
2024-08
0
3.92
2024-09
0
3.64
2024-10
0
4.74
2024-11
0
3.83
2024-12
0
3.3
2025-01
0
6.22
2025-02
0
3.54
2025-03
0
2.87
2025-04
0
3.25
2025-05
0
3.7
2025-06
0
3.51
2025-07
2
3.57
2025-08
0
4.15
2025-09
0
3.08
2025-10
0
3.38
2025-11
0
3.63
2025-12
0
3.85
2026-01
0
3.73
2026-02
0
3.3
2026-03
0
3.6
2026-04
0
3.13
2026-05
0
3.86
2026-06
0
3.28
This device (reports/month)Average device in MAX, OLO (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives 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.