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
2.09
2019-02
0
1.61
2019-03
0
1.58
2019-04
0
2.05
2019-05
0
1.79
2019-06
0
1.82
2019-07
0
2.09
2019-08
0
2.02
2019-09
0
1.66
2019-10
0
1.73
2019-11
0
2.01
2019-12
0
2.48
2020-01
0
2.46
2020-02
0
2.13
2020-03
0
1.87
2020-04
0
1.87
2020-05
0
1.7
2020-06
0
2.08
2020-07
0
2.58
2020-08
0
2.42
2020-09
0
2.46
2020-10
0
2.19
2020-11
0
2.76
2020-12
0
2.38
2021-01
0
1.83
2021-02
0
2.25
2021-03
0
2.54
2021-04
0
2.67
2021-05
0
2.36
2021-06
0
2.17
2021-07
0
2.23
2021-08
0
2.28
2021-09
0
2.29
2021-10
0
2.06
2021-11
0
2.21
2021-12
0
2.32
2022-01
0
2.83
2022-02
0
2.24
2022-03
0
1.99
2022-04
0
1.9
2022-05
0
2.31
2022-06
0
2.25
2022-07
0
2.19
2022-08
0
2.47
2022-09
0
3.06
2022-10
0
3.01
2022-11
0
3.08
2022-12
2
5.07
2023-01
0
2.79
2023-02
0
2.96
2023-03
0
3.27
2023-04
0
2.8
2023-05
0
3.42
2023-06
0
3.07
2023-07
0
2.34
2023-08
0
2.16
2023-09
0
1.99
2023-10
0
2.09
2023-11
0
1.83
2023-12
0
2.39
2024-01
0
2.77
2024-02
0
1.81
2024-03
0
2.33
2024-04
0
2.1
2024-05
0
2.25
2024-06
0
2.26
2024-07
0
2.36
2024-08
0
2.11
2024-09
0
2.16
2024-10
0
2.21
2024-11
0
2.15
2024-12
0
2.73
2025-01
0
2.31
2025-02
0
2.26
2025-03
0
2.11
2025-04
0
2.87
2025-05
0
2.55
2025-06
0
2.02
2025-07
0
2.21
2025-08
0
2.41
2025-09
0
2.15
2025-10
0
2.53
2025-11
0
2.22
2025-12
0
2.86
2026-01
0
2.14
2026-02
0
2.46
2026-03
0
2.59
2026-04
0
2.16
2026-05
0
2.57
2026-06
0
2.33
This device (reports/month)Average device in HWC, JDS (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.