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
2.23
2019-02
0
2.95
2019-03
0
1.95
2019-04
0
2.54
2019-05
0
2.58
2019-06
0
2.13
2019-07
0
2.88
2019-08
0
2.31
2019-09
0
2.59
2019-10
0
3.55
2019-11
0
2.61
2019-12
0
3.08
2020-01
0
2.65
2020-02
0
2.14
2020-03
0
2.57
2020-04
0
2.06
2020-05
0
2.2
2020-06
0
2.79
2020-07
0
3.4
2020-08
0
3.22
2020-09
0
3.04
2020-10
0
3.82
2020-11
0
4.24
2020-12
0
3.5
2021-01
0
4.53
2021-02
0
3.6
2021-03
0
3.73
2021-04
0
3.42
2021-05
0
3.39
2021-06
0
3.09
2021-07
0
3.34
2021-08
0
2.55
2021-09
0
3.23
2021-10
0
2.68
2021-11
0
3.38
2021-12
0
3.64
2022-01
0
3.69
2022-02
0
3.36
2022-03
0
3.02
2022-04
0
3.35
2022-05
0
2.79
2022-06
0
2.88
2022-07
0
3.37
2022-08
0
3.33
2022-09
0
4.38
2022-10
0
2.97
2022-11
0
3.63
2022-12
0
3.15
2023-01
0
3.5
2023-02
0
3.32
2023-03
0
3.94
2023-04
0
3.01
2023-05
0
4.21
2023-06
0
3.57
2023-07
0
3.65
2023-08
0
2.96
2023-09
0
2.53
2023-10
0
2.7
2023-11
0
2.46
2023-12
0
2.32
2024-01
0
2.51
2024-02
0
2.89
2024-03
0
2.61
2024-04
0
2.38
2024-05
0
3.31
2024-06
0
3
2024-07
0
3.19
2024-08
0
2.25
2024-09
0
3.85
2024-10
0
2.67
2024-11
0
2.56
2024-12
0
1.94
2025-01
0
5.71
2025-02
0
4.27
2025-03
0
2.71
2025-04
0
2.89
2025-05
0
3.18
2025-06
0
2.74
2025-07
0
2.97
2025-08
0
3.06
2025-09
0
2.47
2025-10
1
2.19
2025-11
0
2.86
2025-12
0
3.46
2026-01
0
3.06
2026-02
0
2.46
2026-03
0
2.72
2026-04
0
2.96
2026-05
0
2.98
2026-06
0
3.27
This device (reports/month)Average device in HXX (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.