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.
6 linked reportsInjury 6
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
1.65
2019-02
0
1.49
2019-03
0
1.73
2019-04
0
1.87
2019-05
0
1.55
2019-06
0
1.25
2019-07
0
1.43
2019-08
0
1.45
2019-09
0
1.41
2019-10
0
1.5
2019-11
0
1.35
2019-12
0
1.42
2020-01
0
1.68
2020-02
0
1.39
2020-03
0
1.51
2020-04
0
1.46
2020-05
0
1.45
2020-06
0
1.45
2020-07
0
1.47
2020-08
0
1.29
2020-09
0
1.42
2020-10
0
1.32
2020-11
0
1.43
2020-12
0
1.6
2021-01
0
1.69
2021-02
0
1.36
2021-03
0
1.37
2021-04
2
1.32
2021-05
0
1.31
2021-06
2
1.4
2021-07
0
1.36
2021-08
0
1.34
2021-09
0
1.44
2021-10
0
1.42
2021-11
0
1.32
2021-12
0
1.41
2022-01
0
1.31
2022-02
0
1.3
2022-03
0
1.32
2022-04
2
1.44
2022-05
0
1.44
2022-06
0
1.47
2022-07
0
1.33
2022-08
0
1.46
2022-09
0
1.49
2022-10
0
1.36
2022-11
0
1.36
2022-12
0
1.34
2023-01
0
2.1
2023-02
0
1.52
2023-03
0
1.41
2023-04
0
1.39
2023-05
0
1.35
2023-06
0
1.33
2023-07
0
1.36
2023-08
0
1.29
2023-09
0
1.31
2023-10
0
1.27
2023-11
0
1.18
2023-12
0
1.18
2024-01
0
1.34
2024-02
0
1.3
2024-03
0
1.48
2024-04
0
1.13
2024-05
0
1.17
2024-06
0
1.28
2024-07
0
1.24
2024-08
0
1.23
2024-09
0
1.3
2024-10
0
1.39
2024-11
0
1.32
2024-12
0
1.27
2025-01
0
1.49
2025-02
0
1.27
2025-03
0
1.75
2025-04
0
1.61
2025-05
0
1.33
2025-06
0
1.54
2025-07
0
1.64
2025-08
0
1.36
2025-09
0
1.42
2025-10
0
1.56
2025-11
0
1.51
2025-12
0
1.54
2026-01
0
1.65
2026-02
0
1.3
2026-03
0
1.53
2026-04
0
1.59
2026-05
0
1.27
2026-06
0
1.32
This device (reports/month)Average device in KWY (reports/device/month)
Failure-mode summaryAI-generated
6 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.