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.
186 linked reportsMalfunction 183Injury 3
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
3.63
2019-02
0
3.47
2019-03
0
6.65
2019-04
0
5.33
2019-05
0
3.84
2019-06
0
4.13
2019-07
0
3.97
2019-08
0
5.07
2019-09
0
4.04
2019-10
0
4.08
2019-11
0
4.92
2019-12
0
4.9
2020-01
0
4.4
2020-02
0
3.85
2020-03
0
4.71
2020-04
0
4.38
2020-05
0
2.91
2020-06
0
5.59
2020-07
0
5.3
2020-08
0
4.34
2020-09
0
4.43
2020-10
0
4.86
2020-11
0
4.61
2020-12
0
5.15
2021-01
0
4.43
2021-02
0
4.85
2021-03
0
5.58
2021-04
0
4.33
2021-05
0
4.46
2021-06
0
5.41
2021-07
0
4.46
2021-08
0
4.65
2021-09
0
3.79
2021-10
0
3.05
2021-11
0
4.11
2021-12
0
3.53
2022-01
0
3.42
2022-02
0
3.14
2022-03
0
3.33
2022-04
0
3.66
2022-05
0
2.9
2022-06
0
4.17
2022-07
0
3.85
2022-08
0
4.25
2022-09
0
3.68
2022-10
0
3.9
2022-11
0
4.43
2022-12
0
4.24
2023-01
0
3.46
2023-02
0
3.87
2023-03
0
4.25
2023-04
0
4.18
2023-05
0
4.89
2023-06
1
3.97
2023-07
0
4.53
2023-08
0
3.58
2023-09
1
3.89
2023-10
0
3.49
2023-11
0
3.68
2023-12
1
3.38
2024-01
1
4.02
2024-02
3
4.52
2024-03
0
4.16
2024-04
5
4.2
2024-05
1
3.15
2024-06
0
3.45
2024-07
1
3.53
2024-08
5
3.48
2024-09
19
5.09
2024-10
6
3.83
2024-11
8
3.54
2024-12
6
3.63
2025-01
8
3.21
2025-02
9
7.11
2025-03
28
6.45
2025-04
3
3.01
2025-05
9
4.04
2025-06
3
3.42
2025-07
18
4.07
2025-08
8
3.49
2025-09
10
3.15
2025-10
10
3.97
2025-11
10
3.17
2025-12
1
3.28
2026-01
0
2.62
2026-02
3
3.27
2026-03
5
3.63
2026-04
3
4.94
2026-05
0
3.86
2026-06
0
3.56
This device (reports/month)Average device in ERL, HBC (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.