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.
10 linked reportsInjury 10
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
1.76
2019-02
0
1.47
2019-03
0
1.62
2019-04
0
1.54
2019-05
0
1.8
2019-06
0
1.79
2019-07
0
1.33
2019-08
0
2.03
2019-09
1
1.58
2019-10
0
1.7
2019-11
0
1.65
2019-12
0
1.68
2020-01
0
2.04
2020-02
0
2.18
2020-03
0
1.45
2020-04
0
1.67
2020-05
0
1.63
2020-06
0
1.87
2020-07
0
1.97
2020-08
0
1.85
2020-09
0
2
2020-10
0
1.86
2020-11
0
1.8
2020-12
0
1.76
2021-01
0
1.91
2021-02
0
2.13
2021-03
0
2.08
2021-04
0
2.03
2021-05
0
1.8
2021-06
0
1.51
2021-07
0
2.02
2021-08
0
2.24
2021-09
0
1.85
2021-10
0
2
2021-11
4
2.03
2021-12
0
1.91
2022-01
2
2.28
2022-02
0
2.27
2022-03
0
1.85
2022-04
0
2.12
2022-05
0
2.01
2022-06
0
2.08
2022-07
0
2.32
2022-08
0
1.95
2022-09
0
1.92
2022-10
0
1.88
2022-11
1
1.76
2022-12
0
1.79
2023-01
0
1.81
2023-02
0
1.62
2023-03
1
2.02
2023-04
0
1.97
2023-05
0
2.02
2023-06
0
2.12
2023-07
0
1.9
2023-08
0
1.47
2023-09
0
1.31
2023-10
0
1.57
2023-11
0
1.48
2023-12
1
1.35
2024-01
0
1.44
2024-02
0
1.43
2024-03
0
1.41
2024-04
0
1.69
2024-05
0
1.35
2024-06
0
1.84
2024-07
0
1.34
2024-08
0
1.64
2024-09
0
1.42
2024-10
0
1.58
2024-11
0
1.38
2024-12
0
1.4
2025-01
0
1.57
2025-02
0
1.45
2025-03
0
1.68
2025-04
0
1.5
2025-05
0
1.5
2025-06
0
1.64
2025-07
0
1.58
2025-08
0
1.48
2025-09
0
1.43
2025-10
0
1.47
2025-11
0
1.79
2025-12
0
2.03
2026-01
0
1.69
2026-02
0
1.75
2026-03
0
1.5
2026-04
0
1.67
2026-05
0
1.5
2026-06
0
1.67
This device (reports/month)Average device in HSD (reports/device/month)
Failure-mode summaryAI-generated
10 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.