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
2019-02
0
1
2019-04
0
4
2019-05
0
1
2019-06
0
1
2019-08
0
1.67
2019-09
0
5
2019-10
0
1
2019-11
0
1
2020-01
0
1
2020-02
0
2.67
2020-03
0
4.5
2020-04
0
6.67
2020-05
0
7
2020-06
0
11.5
2020-07
0
24
2020-08
0
16
2020-09
0
23.5
2020-10
0
14.25
2020-11
0
37
2020-12
0
40
2021-01
0
23
2021-02
0
16.25
2021-03
0
24
2021-04
0
28.67
2021-05
0
16.75
2021-06
0
23.5
2021-07
0
23.67
2021-08
0
42.5
2021-09
0
37
2021-10
0
34.5
2021-11
0
58.5
2021-12
0
38
2022-01
0
44.67
2022-02
0
48
2022-03
0
31.5
2022-04
0
32.5
2022-05
0
54.5
2022-06
0
22.2
2022-07
0
30
2022-08
0
61
2022-09
0
24.5
2022-10
0
15.33
2022-11
0
50
2022-12
0
13.33
2023-01
0
21.5
2023-02
0
43
2023-03
0
31.67
2023-04
0
22.5
2023-05
0
14.33
2023-06
0
66
2023-07
0
16
2023-08
0
22
2023-09
0
21.33
2023-10
0
27
2023-11
0
28.33
2023-12
0
27
2024-01
0
42.5
2024-02
0
49
2024-03
0
35.5
2024-04
0
19
2024-05
0
22.67
2024-06
0
31
2024-07
0
37.5
2024-08
0
84
2024-09
0
64
2024-10
0
41.25
2024-11
0
23.75
2024-12
0
17
2025-01
0
8
2025-02
0
6
2025-03
0
5.33
2025-04
0
3.25
2025-05
0
2.8
2025-06
0
4.6
2025-07
0
3.33
2025-08
0
7.4
2025-09
0
6.33
2025-10
0
15
2025-11
0
7.75
2025-12
0
5.33
2026-01
0
2.5
2026-02
0
3.83
2026-03
0
8
2026-04
0
4
2026-05
0
3.5
2026-06
1
4.33
This device (reports/month)Average device in FCX (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.