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 reportsDeath 1Injury 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
4.17
2019-02
0
4.13
2019-03
0
3
2019-04
0
4.05
2019-05
0
2.42
2019-06
0
4.63
2019-07
0
5.06
2019-08
0
9
2019-09
0
10
2019-10
0
16.45
2019-11
0
22.37
2019-12
0
16.65
2020-01
0
13.35
2020-02
0
7.26
2020-03
0
6.61
2020-04
0
5.63
2020-05
0
4.27
2020-06
0
5
2020-07
0
3.76
2020-08
0
2.79
2020-09
0
4.87
2020-10
0
3.6
2020-11
0
7.82
2020-12
0
4.41
2021-01
0
4.47
2021-02
0
6.83
2021-03
0
5.9
2021-04
0
9.89
2021-05
0
5.38
2021-06
0
4.56
2021-07
0
3.69
2021-08
0
4.06
2021-09
0
2.84
2021-10
0
3.2
2021-11
0
2.81
2021-12
0
2.73
2022-01
0
3
2022-02
0
2.38
2022-03
0
3.72
2022-04
0
2.47
2022-05
0
2.69
2022-06
2
2.47
2022-07
0
3.32
2022-08
0
1.93
2022-09
0
1.75
2022-10
0
2.61
2022-11
0
2.53
2022-12
0
2.32
2023-01
0
2.18
2023-02
0
2.44
2023-03
0
4.06
2023-04
0
1.95
2023-05
0
1.91
2023-06
0
2.47
2023-07
0
3.5
2023-08
0
4.18
2023-09
0
2
2023-10
0
2
2023-11
0
1.86
2023-12
0
3
2024-01
0
2.59
2024-02
0
3.2
2024-03
0
2.24
2024-04
0
2.16
2024-05
0
3.44
2024-06
0
2.82
2024-07
0
2.46
2024-08
0
2.92
2024-09
0
2.36
2024-10
0
2.94
2024-11
0
2.14
2024-12
0
2.75
2025-01
0
1.83
2025-02
0
2.3
2025-03
0
2.21
2025-04
0
1.94
2025-05
0
2.21
2025-06
0
2.08
2025-07
0
2.29
2025-08
0
1.75
2025-09
0
2.09
2025-10
0
2.43
2025-11
0
1.7
2025-12
0
2.35
2026-01
0
2.41
2026-02
0
3.07
2026-03
0
1.96
2026-04
0
2.1
2026-05
0
1.9
2026-06
0
1.88
This device (reports/month)Average device in LOD, NDN, NKD, PML (reports/device/month)
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.