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.
13 linked reportsMalfunction 9Injury 4
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
8.68
2019-02
0
4.09
2019-03
0
4.28
2019-04
0
5.72
2019-05
0
4.66
2019-06
0
4.69
2019-07
0
5.29
2019-08
0
5.49
2019-09
0
4.89
2019-10
0
5.7
2019-11
0
5.36
2019-12
0
5.38
2020-01
0
4.89
2020-02
0
5.62
2020-03
0
5.67
2020-04
0
3.9
2020-05
0
3.67
2020-06
0
5.28
2020-07
0
6.47
2020-08
0
4.87
2020-09
0
6.3
2020-10
0
6.31
2020-11
0
5.33
2020-12
0
6.21
2021-01
0
5.44
2021-02
0
5.12
2021-03
0
6.3
2021-04
0
5.52
2021-05
0
5.28
2021-06
0
5.8
2021-07
0
4.91
2021-08
0
4.51
2021-09
0
4.47
2021-10
0
5.88
2021-11
0
5.03
2021-12
0
5.53
2022-01
0
5.02
2022-02
0
4.86
2022-03
0
5.39
2022-04
0
4.77
2022-05
0
5.41
2022-06
0
5.79
2022-07
0
4.36
2022-08
0
4.53
2022-09
0
4.78
2022-10
0
4.6
2022-11
0
4.64
2022-12
0
4.19
2023-01
0
5.43
2023-02
0
4.54
2023-03
0
4.96
2023-04
0
4.79
2023-05
0
5.07
2023-06
4
4.7
2023-07
2
4.69
2023-08
0
4.59
2023-09
0
5.12
2023-10
2
4.92
2023-11
1
5.26
2023-12
0
5.91
2024-01
2
5.71
2024-02
0
5.73
2024-03
0
5.93
2024-04
0
6.02
2024-05
0
6.9
2024-06
0
6.3
2024-07
0
5.02
2024-08
0
4.98
2024-09
0
5.08
2024-10
0
5.81
2024-11
0
5.28
2024-12
0
4.95
2025-01
0
6.1
2025-02
0
4.85
2025-03
0
5.97
2025-04
0
4.62
2025-05
0
5.36
2025-06
0
5.08
2025-07
1
5.22
2025-08
0
5.17
2025-09
0
4.78
2025-10
0
5.13
2025-11
0
5.58
2025-12
0
5.84
2026-01
0
5.6
2026-02
0
5.87
2026-03
0
6.06
2026-04
0
5.83
2026-05
0
5.8
2026-06
1
5.42
This device (reports/month)Average device in GEI, HRX (reports/device/month)
Failure-mode summaryAI-generated
13 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.