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.
2 linked reportsMalfunction 2
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
2.24
2019-02
0
3.5
2019-03
0
4.59
2019-04
0
3.35
2019-05
0
3.79
2019-06
0
3.67
2019-07
0
3.16
2019-08
0
3.6
2019-09
0
2.85
2019-10
0
2.91
2019-11
0
3.13
2019-12
0
3.59
2020-01
0
3.15
2020-02
0
5.86
2020-03
0
4.95
2020-04
0
3.06
2020-05
0
2.73
2020-06
0
4.12
2020-07
0
3.77
2020-08
0
3
2020-09
0
4.32
2020-10
0
3.7
2020-11
0
3.74
2020-12
0
4.29
2021-01
0
3.13
2021-02
0
2.87
2021-03
0
3.29
2021-04
0
2.83
2021-05
0
2.64
2021-06
0
3.51
2021-07
0
3.29
2021-08
0
4.43
2021-09
0
3.41
2021-10
0
2.79
2021-11
0
3.37
2021-12
0
3.75
2022-01
0
2.83
2022-02
0
3.7
2022-03
0
3.69
2022-04
0
2.47
2022-05
0
3.29
2022-06
0
3.72
2022-07
0
3
2022-08
0
3.71
2022-09
0
3.9
2022-10
0
3.37
2022-11
0
3.41
2022-12
0
4.53
2023-01
0
3.13
2023-02
0
3.56
2023-03
0
3.74
2023-04
0
3.16
2023-05
0
4.3
2023-06
0
3.86
2023-07
0
2.84
2023-08
0
3.36
2023-09
0
3.37
2023-10
0
2.53
2023-11
0
3.87
2023-12
0
2.58
2024-01
0
3.08
2024-02
0
3.06
2024-03
0
3.24
2024-04
0
2.62
2024-05
0
2.59
2024-06
0
3.18
2024-07
0
2.53
2024-08
1
2.66
2024-09
0
3.46
2024-10
0
2.53
2024-11
0
2.16
2024-12
0
3.3
2025-01
0
2.53
2025-02
0
3.46
2025-03
0
2.24
2025-04
0
1.83
2025-05
0
2.16
2025-06
0
2.51
2025-07
0
2.45
2025-08
0
1.89
2025-09
1
1.86
2025-10
0
2.68
2025-11
0
3
2025-12
0
2.78
2026-01
0
1.99
2026-02
0
2.37
2026-03
0
4.15
2026-04
0
4.26
2026-05
0
4.6
2026-06
0
14.63
This device (reports/month)Average device in HBE, HSZ (reports/device/month)
Failure-mode summaryAI-generated
2 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.