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.
65 linked reportsMalfunction 53Injury 12
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
2.67
2019-02
7
3.61
2019-03
1
3.19
2019-04
0
2.75
2019-05
1
3.1
2019-06
0
2.72
2019-07
1
3.23
2019-08
0
2.93
2019-09
0
2.89
2019-10
0
3.84
2019-11
0
5.54
2019-12
0
3.54
2020-01
1
3.39
2020-02
0
4.56
2020-03
1
4.41
2020-04
0
7.69
2020-05
0
2.37
2020-06
3
3.54
2020-07
0
3.94
2020-08
0
2.61
2020-09
1
3.93
2020-10
0
5.63
2020-11
1
5.77
2020-12
0
4.33
2021-01
0
4.68
2021-02
0
4.08
2021-03
0
3.82
2021-04
1
3.82
2021-05
0
4.15
2021-06
2
3.79
2021-07
0
3.25
2021-08
1
2.96
2021-09
1
2.92
2021-10
0
2.27
2021-11
1
4.24
2021-12
4
2.72
2022-01
3
2.54
2022-02
2
3.16
2022-03
0
3.32
2022-04
1
2.45
2022-05
1
3.91
2022-06
1
4.21
2022-07
0
3.33
2022-08
1
2.9
2022-09
2
2.32
2022-10
0
3.76
2022-11
1
3.44
2022-12
2
4.22
2023-01
2
3.18
2023-02
0
3.44
2023-03
1
3.77
2023-04
0
3.26
2023-05
0
3.02
2023-06
2
2.6
2023-07
0
2.69
2023-08
1
2.51
2023-09
1
4.04
2023-10
0
3.21
2023-11
0
9.13
2023-12
1
4
2024-01
1
3.71
2024-02
1
4.15
2024-03
0
4.4
2024-04
0
3.95
2024-05
0
4.89
2024-06
2
4.54
2024-07
1
3.92
2024-08
0
4.59
2024-09
3
4.53
2024-10
2
6.31
2024-11
0
4.74
2024-12
0
4.01
2025-01
0
8.37
2025-02
3
4.23
2025-03
0
3.59
2025-04
0
4.2
2025-05
0
4.57
2025-06
1
4.14
2025-07
2
4.32
2025-08
0
5.03
2025-09
0
3.85
2025-10
0
3.97
2025-11
0
4.12
2025-12
0
4.59
2026-01
0
4.53
2026-02
0
4.25
2026-03
0
4.08
2026-04
0
3.9
2026-05
0
4.99
2026-06
0
3.99
This device (reports/month)Average device in OLO (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.