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
1.58
2019-02
0
1.1
2019-03
0
1.13
2019-04
0
1.32
2019-05
0
1.5
2019-06
0
1.26
2019-07
0
1.38
2019-08
0
1.34
2019-09
0
1.38
2019-10
0
1.82
2019-11
0
1.48
2019-12
0
1.27
2020-01
0
1.68
2020-02
0
1.36
2020-03
0
1.74
2020-04
0
1.61
2020-05
0
1.5
2020-06
0
1.28
2020-07
0
2.03
2020-08
0
1.89
2020-09
0
1.73
2020-10
0
2.02
2020-11
0
1.91
2020-12
0
2.07
2021-01
0
2.03
2021-02
0
2.21
2021-03
0
1.54
2021-04
0
2.83
2021-05
0
2.91
2021-06
0
1.75
2021-07
0
1.63
2021-08
0
1.63
2021-09
0
1.62
2021-10
0
1.77
2021-11
0
2.05
2021-12
0
1.43
2022-01
0
1.4
2022-02
0
1.98
2022-03
0
1.83
2022-04
0
1.37
2022-05
0
1.62
2022-06
0
1.57
2022-07
0
2.17
2022-08
0
1.52
2022-09
0
1.78
2022-10
0
1.65
2022-11
0
1.9
2022-12
0
1.4
2023-01
0
2.44
2023-02
0
2.17
2023-03
0
2.09
2023-04
0
2.45
2023-05
0
2.51
2023-06
0
2.6
2023-07
0
1.92
2023-08
0
1.43
2023-09
0
1.4
2023-10
0
1.37
2023-11
0
1.5
2023-12
0
1.75
2024-01
0
1.39
2024-02
0
2.08
2024-03
0
1.43
2024-04
0
1.29
2024-05
0
1.44
2024-06
0
1.61
2024-07
0
1.56
2024-08
0
1.82
2024-09
0
1.91
2024-10
0
1.33
2024-11
0
1.46
2024-12
1
1.44
2025-01
0
1.46
2025-02
0
1.29
2025-03
0
1.34
2025-04
0
1.72
2025-05
0
1.33
2025-06
0
1.3
2025-07
0
1.36
2025-08
0
1.94
2025-09
0
1.45
2025-10
0
1.2
2025-11
0
1.52
2025-12
0
1.58
2026-01
0
1.74
2026-02
0
1.65
2026-03
0
1.67
2026-04
0
1.41
2026-05
0
1.47
2026-06
0
1.42
This device (reports/month)Average device in FZX (reports/device/month)