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.
949 linked reportsMalfunction 949
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
12.39
2019-02
0
3.26
2019-03
0
5.22
2019-04
0
11.02
2019-05
0
4.51
2019-06
0
3.78
2019-07
0
3.4
2019-08
0
4.19
2019-09
0
4.66
2019-10
0
5.25
2019-11
0
4.89
2019-12
0
5.36
2020-01
0
5.33
2020-02
0
6.43
2020-03
0
5.4
2020-04
0
5.06
2020-05
0
3.54
2020-06
0
5.69
2020-07
0
5.86
2020-08
0
5.71
2020-09
0
7.31
2020-10
0
9.04
2020-11
0
6.24
2020-12
0
9.15
2021-01
0
6.12
2021-02
0
5.8
2021-03
0
8.38
2021-04
0
6.07
2021-05
0
6.06
2021-06
0
5.79
2021-07
0
4.87
2021-08
0
5.68
2021-09
0
4.17
2021-10
0
5.76
2021-11
1
4.26
2021-12
0
5.67
2022-01
1
6.19
2022-02
1
4.9
2022-03
4
5.79
2022-04
1
5.93
2022-05
3
5.29
2022-06
2
6.05
2022-07
3
6.53
2022-08
3
6.1
2022-09
3
5.86
2022-10
0
5.71
2022-11
2
5.67
2022-12
5
5.81
2023-01
2
6.21
2023-02
0
5.34
2023-03
4
6.94
2023-04
13
6.22
2023-05
10
5.47
2023-06
7
5.4
2023-07
4
5.3
2023-08
6
7.29
2023-09
22
6.75
2023-10
10
6.22
2023-11
13
9.39
2023-12
14
8.66
2024-01
10
6.29
2024-02
27
8.31
2024-03
13
6.66
2024-04
29
7.15
2024-05
20
8.38
2024-06
14
8.9
2024-07
17
6.82
2024-08
20
6.97
2024-09
26
6.28
2024-10
20
7.28
2024-11
23
6.55
2024-12
17
6.38
2025-01
32
7.06
2025-02
22
5.16
2025-03
15
4.81
2025-04
32
5.58
2025-05
32
5.38
2025-06
28
5.12
2025-07
46
5.69
2025-08
25
4.24
2025-09
31
4.25
2025-10
28
4.8
2025-11
33
5.3
2025-12
22
5.31
2026-01
7
4.86
2026-02
51
5.37
2026-03
17
4.94
2026-04
76
6.83
2026-05
59
5.51
2026-06
23
4.93
This device (reports/month)Average device in EOB, HRX (reports/device/month)
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-29
1221934-2026-02826
Malfunction
—
exact di
2026-06-29
1221934-2026-02830
Malfunction
—
exact di
2026-06-16
1221934-2026-02620
Malfunction
Available
catalog number
2026-06-15
1221934-2026-02579
Malfunction
Available
catalog number
2026-06-12
1221934-2026-02549
Malfunction
Available
catalog number
2026-06-12
1221934-2026-02529
Malfunction
Available
exact di
2026-06-12
1221934-2026-02534
Malfunction
Available
exact di
2026-06-09
1221934-2026-02475
Malfunction
Available
exact di
2026-06-09
1221934-2026-02473
Malfunction
Available
exact di
2026-06-08
1221934-2026-02447
Malfunction
Available
exact di
2026-06-08
1221934-2026-02463
Malfunction
Available
catalog number
2026-06-08
1221934-2026-02460
Malfunction
Available
catalog number
2026-06-08
1221934-2026-02450
Malfunction
Available
catalog number
2026-06-08
1221934-2026-02458
Malfunction
Available
catalog number
2026-06-03
1221934-2026-02379
Malfunction
Available
catalog number
Showing the most recent 200 of 949 linked reports.
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.