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.
18 linked reportsInjury 10Malfunction 8
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
1.7
2019-02
0
1.5
2019-03
0
1.5
2019-04
0
3.14
2019-05
0
1.2
2019-06
0
1.5
2019-07
0
1.78
2019-08
0
2.29
2019-09
0
1.6
2019-10
0
2.75
2019-11
0
3.4
2019-12
0
2.17
2020-01
0
1
2020-02
0
2.78
2020-03
0
2.5
2020-04
0
2
2020-05
0
1
2020-06
0
2.38
2020-07
0
3.2
2020-08
0
2.5
2020-09
0
3.57
2020-10
0
2
2020-11
0
2.57
2020-12
0
3.2
2021-01
0
2.67
2021-02
0
3.78
2021-03
0
2.5
2021-04
0
3.23
2021-05
0
2.91
2021-06
0
2.5
2021-07
0
3.4
2021-08
0
1.91
2021-09
0
2.62
2021-10
0
3.73
2021-11
0
2.82
2021-12
0
2.36
2022-01
0
2.2
2022-02
0
4
2022-03
0
3.36
2022-04
0
2.47
2022-05
0
2.7
2022-06
0
2.36
2022-07
0
2.38
2022-08
0
3.08
2022-09
0
4.43
2022-10
0
9.78
2022-11
0
2.79
2022-12
0
2.13
2023-01
0
2.94
2023-02
6
2.35
2023-03
0
4.57
2023-04
0
3.16
2023-05
0
3.15
2023-06
0
3
2023-07
0
3.24
2023-08
0
3.5
2023-09
0
2.71
2023-10
0
4.25
2023-11
0
4.35
2023-12
0
4.33
2024-01
0
8.47
2024-02
0
4.54
2024-03
0
5.08
2024-04
0
5.24
2024-05
0
4.59
2024-06
2
4.71
2024-07
0
3.95
2024-08
2
2.72
2024-09
0
3.68
2024-10
0
2.86
2024-11
0
4.1
2024-12
0
4.11
2025-01
0
4.18
2025-02
0
3.71
2025-03
0
4.25
2025-04
0
2.97
2025-05
4
4.84
2025-06
2
4.23
2025-07
0
4.62
2025-08
0
3.85
2025-09
0
5.33
2025-10
0
5.63
2025-11
0
3.9
2025-12
2
6.91
2026-01
0
4.47
2026-02
0
5.24
2026-03
0
5.22
2026-04
0
5.67
2026-05
0
3.84
2026-06
0
5.86
This device (reports/month)Average device in OBJ (reports/device/month)
Failure-mode summaryAI-generated
18 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.