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.
1 linked reportMalfunction 1
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
2.97
2019-02
0
4.45
2019-03
0
3.6
2019-04
0
3.18
2019-05
0
3.94
2019-06
0
3.31
2019-07
0
3.93
2019-08
0
4.29
2019-09
0
3.48
2019-10
0
4.12
2019-11
0
5.93
2019-12
0
4.32
2020-01
0
3.49
2020-02
0
5.16
2020-03
0
5.07
2020-04
0
8.75
2020-05
0
3.12
2020-06
0
3.41
2020-07
0
3.89
2020-08
0
2.74
2020-09
0
3.53
2020-10
0
5.36
2020-11
0
5.25
2020-12
0
4.21
2021-01
0
4.44
2021-02
0
3.93
2021-03
0
3.77
2021-04
0
3.78
2021-05
0
4.14
2021-06
0
3.67
2021-07
0
3.44
2021-08
0
3.19
2021-09
0
2.86
2021-10
0
2.49
2021-11
0
4.1
2021-12
0
2.91
2022-01
0
2.63
2022-02
0
3.08
2022-03
0
3.38
2022-04
0
2.42
2022-05
0
3.69
2022-06
0
4.19
2022-07
0
3.23
2022-08
0
2.87
2022-09
0
2.38
2022-10
0
3.7
2022-11
0
3.21
2022-12
0
3.77
2023-01
0
3
2023-02
0
3.25
2023-03
0
3.54
2023-04
0
2.97
2023-05
0
2.69
2023-06
0
2.64
2023-07
0
2.7
2023-08
0
2.45
2023-09
0
3.51
2023-10
0
3.27
2023-11
0
7.38
2023-12
0
3.52
2024-01
0
3.38
2024-02
0
3.89
2024-03
0
3.91
2024-04
0
4.13
2024-05
0
4.2
2024-06
0
3.92
2024-07
0
3.73
2024-08
0
4.32
2024-09
0
4.28
2024-10
0
5.72
2024-11
0
4.47
2024-12
1
3.73
2025-01
0
8.02
2025-02
0
4.63
2025-03
0
3.38
2025-04
0
3.86
2025-05
0
4.05
2025-06
0
3.87
2025-07
0
4
2025-08
0
4.85
2025-09
0
3.61
2025-10
0
5.35
2025-11
0
3.9
2025-12
0
5.05
2026-01
0
5.21
2026-02
0
4.28
2026-03
0
7.08
2026-04
0
6.17
2026-05
0
8.19
2026-06
0
5.1
This device (reports/month)Average device in LLZ, OLO (reports/device/month)
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.