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.
112 linked reportsMalfunction 112
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
1.82
2019-02
0
1.85
2019-03
0
1.75
2019-04
0
1.88
2019-05
0
2.1
2019-06
0
1.88
2019-07
0
1.68
2019-08
0
2.18
2019-09
0
1.67
2019-10
0
1.88
2019-11
0
1.72
2019-12
0
1.77
2020-01
0
1.96
2020-02
0
2.08
2020-03
0
2.19
2020-04
0
1.8
2020-05
0
1.66
2020-06
0
1.95
2020-07
0
2.24
2020-08
0
1.76
2020-09
0
1.96
2020-10
0
2.2
2020-11
0
1.9
2020-12
0
1.87
2021-01
0
2.2
2021-02
0
1.99
2021-03
0
2.15
2021-04
0
2.02
2021-05
0
2.02
2021-06
0
1.91
2021-07
0
2.06
2021-08
0
2.19
2021-09
0
1.97
2021-10
0
2.18
2021-11
0
2.13
2021-12
1
2.6
2022-01
0
2.65
2022-02
1
2.35
2022-03
0
2.51
2022-04
1
2.48
2022-05
2
2.13
2022-06
0
2.24
2022-07
0
2.2
2022-08
4
2.27
2022-09
3
2.04
2022-10
1
2.12
2022-11
5
2.16
2022-12
2
2.1
2023-01
1
1.85
2023-02
2
2.06
2023-03
2
2.05
2023-04
4
2.22
2023-05
3
2.12
2023-06
1
2.32
2023-07
3
2.11
2023-08
3
1.76
2023-09
0
1.59
2023-10
1
1.64
2023-11
2
1.69
2023-12
2
1.46
2024-01
4
1.9
2024-02
3
1.89
2024-03
5
1.73
2024-04
2
1.87
2024-05
1
1.72
2024-06
1
1.89
2024-07
0
1.63
2024-08
0
1.73
2024-09
1
1.74
2024-10
3
1.73
2024-11
2
1.64
2024-12
1
1.67
2025-01
0
1.74
2025-02
1
1.65
2025-03
5
1.94
2025-04
4
1.73
2025-05
3
1.83
2025-06
1
1.96
2025-07
2
1.8
2025-08
1
1.61
2025-09
3
1.52
2025-10
1
1.69
2025-11
3
1.74
2025-12
3
2.19
2026-01
1
1.93
2026-02
2
1.85
2026-03
5
1.8
2026-04
4
1.74
2026-05
3
1.8
2026-06
3
1.8
This device (reports/month)Average device in KWS, PHX (reports/device/month)
Failure-mode summaryAI-generated
40 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.