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.
13 linked reportsMalfunction 13
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
10.56
2019-02
0
12.69
2019-03
0
11.63
2019-04
0
12.46
2019-05
0
12.27
2019-06
0
10.34
2019-07
0
11.67
2019-08
0
16.27
2019-09
0
12.2
2019-10
0
13.33
2019-11
0
16.63
2019-12
1
20.13
2020-01
0
14.15
2020-02
0
18.53
2020-03
0
17.04
2020-04
0
19.1
2020-05
0
30.98
2020-06
0
17.15
2020-07
0
24.74
2020-08
4
28.38
2020-09
1
74.85
2020-10
1
99.6
2020-11
1
192.07
2020-12
1
385.31
2021-01
2
264.09
2021-02
0
106.71
2021-03
0
77.38
2021-04
0
78.29
2021-05
1
72.41
2021-06
0
74.45
2021-07
0
89.1
2021-08
0
111.07
2021-09
0
151.73
2021-10
0
318.48
2021-11
0
385.2
2021-12
0
1212.16
2022-01
0
2694.92
2022-02
0
1413.28
2022-03
0
2239.43
2022-04
0
2411.59
2022-05
0
1936.71
2022-06
0
1803.15
2022-07
0
888.18
2022-08
0
227.64
2022-09
0
287.35
2022-10
0
256.49
2022-11
1
245.91
2022-12
0
228.98
2023-01
0
127.34
2023-02
0
255.75
2023-03
0
305.05
2023-04
0
263.63
2023-05
0
240.84
2023-06
0
298.8
2023-07
0
281.34
2023-08
0
268.34
2023-09
0
219.98
2023-10
0
129.77
2023-11
0
130.95
2023-12
0
63.55
2024-01
0
67.35
2024-02
0
101.17
2024-03
0
71.21
2024-04
0
76.75
2024-05
0
46.49
2024-06
0
50.21
2024-07
0
45.53
2024-08
0
41.36
2024-09
0
48.22
2024-10
0
50.88
2024-11
0
57.8
2024-12
0
53.16
2025-01
0
64.36
2025-02
0
57.67
2025-03
0
83.62
2025-04
0
71.4
2025-05
0
81.16
2025-06
0
87.33
2025-07
0
119.88
2025-08
0
83.67
2025-09
0
81.89
2025-10
0
93.65
2025-11
0
83
2025-12
0
88.56
2026-01
0
74.52
2026-02
0
76.73
2026-03
0
87.13
2026-04
0
143.63
2026-05
0
327.5
2026-06
0
351.16
This device (reports/month)Average device in FRN, LGZ (reports/device/month)
Failure-mode summaryAI-generated
13 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.