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 reportInjury 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
2019-02
0
1.5
2019-03
0
1
2019-04
0
2
2019-05
0
1
2019-06
0
1
2019-07
0
2
2019-08
0
2.67
2019-09
0
1
2019-10
0
1
2019-11
0
1.5
2020-01
0
1
2020-02
0
1.33
2020-03
0
7.67
2020-04
0
2
2020-05
0
1
2020-06
0
1.8
2020-07
0
4
2020-08
0
2.5
2020-09
0
7.57
2020-10
0
6.13
2020-11
0
6.33
2020-12
0
20.45
2021-01
0
5.17
2021-02
0
4
2021-03
0
5.7
2021-04
0
15
2021-05
0
3
2021-06
0
2
2021-08
0
5.33
2021-09
0
3
2021-10
0
8
2021-11
0
3.8
2021-12
0
1
2022-01
0
4
2022-02
0
2.67
2022-03
0
4
2022-04
0
2.17
2022-05
0
2.25
2022-06
0
5.33
2022-07
0
3
2022-08
0
1.33
2022-09
0
30.33
2022-10
0
5
2022-11
0
4.33
2023-01
0
6
2023-02
0
2.25
2023-03
0
2
2023-04
0
2.67
2023-05
0
2
2023-06
0
5
2023-07
0
1.5
2023-08
0
4.4
2023-09
0
125
2023-10
0
194.75
2023-11
0
68
2023-12
0
10
2024-01
0
11.67
2024-02
0
37
2024-04
0
8
2024-05
0
3
2024-06
0
17.75
2024-07
0
100
2024-08
0
7.5
2024-09
0
144
2024-10
0
26.27
2024-11
0
6.75
2024-12
1
1.33
2025-01
0
65.83
2025-02
0
228.5
2025-03
0
23.75
2025-04
0
2
2025-05
0
21.18
2025-06
0
28.4
2025-07
0
15.67
2025-08
0
12.67
2025-09
0
49.14
2025-10
0
8.4
2025-11
0
69
2025-12
0
76.5
2026-01
0
53
2026-02
0
13.5
2026-03
0
10.4
2026-04
0
49.25
2026-05
0
11
2026-06
0
4
This device (reports/month)Average device in NAD (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.