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.
4 linked reportsInjury 4
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
5.05
2019-02
0
6.94
2019-03
0
5.26
2019-04
0
6.35
2019-05
0
7.39
2019-06
0
6.44
2019-07
0
5.53
2019-08
0
12.69
2019-09
0
6.07
2019-10
0
4.24
2019-11
0
5.38
2019-12
0
7.71
2020-01
0
3
2020-02
0
6.23
2020-03
0
7.53
2020-04
0
11.73
2020-05
0
3.75
2020-06
1
2.53
2020-07
0
2.7
2020-08
0
2.41
2020-09
0
1.94
2020-10
0
2.39
2020-11
0
2.29
2020-12
0
2.8
2021-01
0
2.04
2021-02
0
2.19
2021-03
0
2.82
2021-04
0
3
2021-05
0
3.84
2021-06
0
4
2021-07
0
3.74
2021-08
0
3.15
2021-09
0
2.35
2021-10
0
2.52
2021-11
0
2.91
2021-12
0
3.33
2022-01
0
2.28
2022-02
0
2.62
2022-03
0
2.88
2022-04
0
2.31
2022-05
0
1.83
2022-06
0
2.53
2022-07
0
3.26
2022-08
1
2.13
2022-09
0
2.82
2022-10
0
2.65
2022-11
0
2.12
2022-12
0
1.88
2023-01
0
2.29
2023-02
0
2.09
2023-03
0
2.55
2023-04
1
2.23
2023-05
0
2.15
2023-06
0
5.47
2023-07
0
2.39
2023-08
0
3.13
2023-09
0
2.51
2023-10
0
4.97
2023-11
0
2.41
2023-12
0
2.4
2024-01
0
2
2024-02
1
2.33
2024-03
0
2.33
2024-04
0
3.23
2024-05
0
2.37
2024-06
0
2.75
2024-07
0
2.51
2024-08
0
2.68
2024-09
0
2.55
2024-10
0
2.65
2024-11
0
2.32
2024-12
0
2.03
2025-01
0
4.62
2025-02
0
4.55
2025-03
0
2.09
2025-04
0
2.24
2025-05
0
2.49
2025-06
0
2.46
2025-07
0
2.51
2025-08
0
2.87
2025-09
0
2.49
2025-10
0
7.33
2025-11
0
2.37
2025-12
0
5.18
2026-01
0
5.92
2026-02
0
3.24
2026-03
0
12.28
2026-04
0
8.33
2026-05
0
12.16
2026-06
0
5.26
This device (reports/month)Average device in JAK, LLZ (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2024-02-01
8043933-2024-00004
Injury
Available
exact di
2023-04-19
8043933-2023-00027
Injury
Available
exact di
2022-08-12
8043933-2022-00047
Injury
Available
exact di
2020-06-13
8043933-2020-00026
Injury
Available
exact di
Regulatory clearances
510(k)K212420Substantially equivalent (SESE) · 2021-12-16clearance family
510(k)K170816Substantially equivalent (SESE) · 2017-09-26clearance family
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.