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 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
4.67
2019-02
0
9.4
2019-03
0
7.11
2019-04
0
6.8
2019-05
0
11
2019-06
0
8.82
2019-07
0
10.67
2019-08
0
15.7
2019-09
0
8.56
2019-10
0
5.44
2019-11
0
6.78
2019-12
0
10.33
2020-01
0
4.11
2020-02
0
8.23
2020-03
0
8.27
2020-04
0
9.77
2020-05
0
5.38
2020-06
0
2.45
2020-07
0
3.25
2020-08
2
3.06
2020-09
0
2.6
2020-10
0
3.1
2020-11
0
2.31
2020-12
0
3.42
2021-01
0
2.69
2021-02
0
2.82
2021-03
0
3.46
2021-04
0
3.18
2021-05
0
3.67
2021-06
0
3.32
2021-07
0
4.38
2021-08
0
3.8
2021-09
0
2.2
2021-10
0
2.88
2021-11
0
2.87
2021-12
0
4.08
2022-01
0
5
2022-02
0
2.5
2022-03
0
3
2022-04
0
2
2022-05
0
1.58
2022-06
0
3.5
2022-07
0
2.93
2022-08
0
3.15
2022-09
0
5
2022-10
0
3
2022-11
0
1.94
2022-12
0
2.14
2023-01
0
2.27
2023-02
0
2.27
2023-03
1
2.39
2023-04
0
2.14
2023-05
0
1.58
2023-06
0
2.79
2023-07
0
2.56
2023-08
0
2.11
2023-09
0
2
2023-10
0
3.58
2023-11
0
2.1
2023-12
0
1.87
2024-01
0
2
2024-02
0
2.76
2024-03
0
2.33
2024-04
0
4.53
2024-05
0
2.42
2024-06
0
2.44
2024-07
0
2.95
2024-08
0
3.22
2024-09
0
3.36
2024-10
0
3.09
2024-11
0
3.28
2024-12
0
2.28
2025-01
0
6.17
2025-02
0
6.5
2025-03
0
2.58
2025-04
0
2.36
2025-05
0
2.35
2025-06
0
2.8
2025-07
0
2.79
2025-08
0
3.78
2025-09
0
2.86
2025-10
0
9.4
2025-11
1
2.83
2025-12
0
6.03
2026-01
0
6.9
2026-02
0
3.84
2026-03
0
13.11
2026-04
0
11.4
2026-05
0
16.65
2026-06
0
9.38
This device (reports/month)Average device in DZJ, LLZ (reports/device/month)
Failure-mode summaryAI-generated
4 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.