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
3.43
2019-02
0
1.59
2019-03
0
2.17
2019-04
0
2.6
2019-05
0
2.06
2019-06
0
2
2019-07
0
2.17
2019-08
0
1.97
2019-09
1
2.88
2019-10
0
2.58
2019-11
0
2.43
2019-12
0
2.66
2020-01
0
2.43
2020-02
0
2.5
2020-03
0
2.5
2020-04
0
3.56
2020-05
0
2.27
2020-06
0
2.94
2020-07
0
2.2
2020-08
0
2.95
2020-09
0
2.58
2020-10
0
2.7
2020-11
0
3.63
2020-12
0
3.2
2021-01
0
2.14
2021-02
0
2.88
2021-03
0
2.74
2021-04
0
2.08
2021-05
0
3.2
2021-06
0
2.91
2021-07
0
2.32
2021-08
0
2.05
2021-09
0
3.35
2021-10
0
2.45
2021-11
0
3.72
2021-12
0
2.88
2022-01
0
3.39
2022-02
0
2.95
2022-03
0
3.19
2022-04
0
2.93
2022-05
0
2.62
2022-06
0
2.61
2022-07
0
2.8
2022-08
0
3.46
2022-09
0
3.33
2022-10
0
4.5
2022-11
0
2.52
2022-12
0
2.79
2023-01
0
4.3
2023-02
0
2.56
2023-03
0
3.29
2023-04
0
3.44
2023-05
0
3.35
2023-06
0
4.83
2023-07
0
2.43
2023-08
0
2.88
2023-09
0
3.62
2023-10
0
2.61
2023-11
0
3.35
2023-12
0
3.17
2024-01
0
3.43
2024-02
0
2.5
2024-03
0
3.09
2024-04
0
2.73
2024-05
0
3.03
2024-06
0
3.81
2024-07
0
2.78
2024-08
0
3.86
2024-09
0
3.52
2024-10
0
3.24
2024-11
0
3.84
2024-12
0
3.48
2025-01
0
4.5
2025-02
0
2.76
2025-03
0
3.17
2025-04
0
3
2025-05
0
3.31
2025-06
0
3.33
2025-07
0
3.54
2025-08
0
3.62
2025-09
0
4.14
2025-10
0
3.95
2025-11
0
4.06
2025-12
0
4.14
2026-01
0
4.23
2026-02
0
4.77
2026-03
0
4.19
2026-04
0
3.55
2026-05
0
7.03
2026-06
0
5.16
This device (reports/month)Average device in JDR (reports/device/month)
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2019-09-30
3007420745-2019-00042
Injury
Available
model number
Regulatory clearances
510(k)K162354Substantially equivalent (SESE) · 2017-04-20clearance 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.