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.
4 linked reportsInjury 2Malfunction 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
2.64
2019-02
0
2.09
2019-03
0
1.87
2019-04
0
2.35
2019-05
0
1.85
2019-06
0
2.09
2019-07
0
2.65
2019-08
0
2.25
2019-09
0
1.67
2019-10
0
2.76
2019-11
0
2.08
2019-12
0
2.23
2020-01
0
2.96
2020-02
0
2.5
2020-03
0
2.36
2020-04
0
2.69
2020-05
0
2.37
2020-06
0
2.44
2020-07
0
3.14
2020-08
0
2.44
2020-09
0
2.41
2020-10
0
3.14
2020-11
0
2.58
2020-12
0
2.81
2021-01
0
2.67
2021-02
0
2.62
2021-03
0
2.46
2021-04
0
2.16
2021-05
0
2.79
2021-06
0
2.43
2021-07
0
2.1
2021-08
0
2.55
2021-09
0
2.21
2021-10
0
2.4
2021-11
0
2.22
2021-12
0
2.41
2022-01
0
2.35
2022-02
0
2.4
2022-03
0
2.07
2022-04
0
2.28
2022-05
0
1.91
2022-06
0
2.46
2022-07
0
2.14
2022-08
0
2.32
2022-09
0
2.2
2022-10
0
2.38
2022-11
0
2.09
2022-12
0
2.03
2023-01
0
1.93
2023-02
0
2.13
2023-03
0
2.08
2023-04
0
2.31
2023-05
0
2.07
2023-06
0
2.39
2023-07
0
2.16
2023-08
0
2.23
2023-09
1
2.06
2023-10
0
2.56
2023-11
0
2.61
2023-12
0
2.5
2024-01
0
2.08
2024-02
0
2.29
2024-03
0
1.97
2024-04
0
2.19
2024-05
0
2.07
2024-06
0
2.1
2024-07
0
2.14
2024-08
0
2.19
2024-09
0
2.29
2024-10
0
2.45
2024-11
2
2.6
2024-12
0
3.04
2025-01
0
2.92
2025-02
0
2.85
2025-03
0
2.63
2025-04
0
2.6
2025-05
0
2.6
2025-06
0
3.25
2025-07
0
3.31
2025-08
0
2.82
2025-09
0
2.9
2025-10
0
3.24
2025-11
0
3.24
2025-12
0
3.8
2026-01
0
3.65
2026-02
1
3.27
2026-03
0
3.21
2026-04
0
3.28
2026-05
0
3.52
2026-06
0
3.53
This device (reports/month)Average device in DQY, NRY, QJP (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.