The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
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.
14 linked reportsInjury 14
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
1.92
2019-02
0
1.88
2019-03
0
1.76
2019-04
0
2
2019-05
0
2.21
2019-06
0
1.84
2019-07
0
1.74
2019-08
0
2.29
2019-09
0
1.79
2019-10
0
1.84
2019-11
0
1.76
2019-12
0
1.74
2020-01
0
2.04
2020-02
1
2.08
2020-03
1
2.17
2020-04
0
1.81
2020-05
1
1.8
2020-06
0
2
2020-07
2
2.34
2020-08
2
1.88
2020-09
0
2.01
2020-10
0
2.12
2020-11
0
1.89
2020-12
0
1.85
2021-01
0
2.23
2021-02
2
2.2
2021-03
0
2.24
2021-04
0
2.2
2021-05
1
2.07
2021-06
0
1.95
2021-07
0
2.19
2021-08
0
2.35
2021-09
0
2.13
2021-10
0
2.45
2021-11
0
2.2
2021-12
0
2.73
2022-01
0
2.85
2022-02
0
2.61
2022-03
0
2.89
2022-04
0
2.66
2022-05
0
2.26
2022-06
0
2.37
2022-07
0
2.37
2022-08
0
2.35
2022-09
0
2.14
2022-10
0
2.2
2022-11
0
2.12
2022-12
0
2.17
2023-01
0
1.95
2023-02
0
1.98
2023-03
0
2.14
2023-04
0
2.34
2023-05
0
2.18
2023-06
3
2.28
2023-07
0
2.04
2023-08
0
1.72
2023-09
0
1.53
2023-10
0
1.67
2023-11
0
1.66
2023-12
0
1.44
2024-01
0
1.61
2024-02
0
1.79
2024-03
0
1.64
2024-04
0
1.88
2024-05
0
1.58
2024-06
0
1.86
2024-07
0
1.53
2024-08
0
1.72
2024-09
1
1.63
2024-10
0
1.75
2024-11
0
1.57
2024-12
0
1.58
2025-01
0
1.68
2025-02
0
1.64
2025-03
0
1.9
2025-04
0
1.71
2025-05
0
1.73
2025-06
0
1.9
2025-07
0
1.76
2025-08
0
1.63
2025-09
0
1.49
2025-10
0
1.63
2025-11
0
1.78
2025-12
0
2.18
2026-01
0
1.88
2026-02
0
1.86
2026-03
0
1.73
2026-04
0
1.73
2026-05
0
1.71
2026-06
0
1.83
This device (reports/month)Average device in HSD, PHX (reports/device/month)
Failure-mode summaryAI-generated
14 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.