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.
63 linked reportsMalfunction 63
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
2.77
2019-02
0
2.39
2019-03
0
2.71
2019-04
0
2.6
2019-05
0
2.06
2019-06
0
1.75
2019-07
0
1.77
2019-08
0
2.02
2019-09
0
2.2
2019-10
0
2.38
2019-11
0
2.03
2019-12
0
2.28
2020-01
0
2.59
2020-02
0
2.32
2020-03
0
2.93
2020-04
1
2.08
2020-05
0
2.07
2020-06
2
1.91
2020-07
0
2.32
2020-08
0
1.89
2020-09
0
2.34
2020-10
0
2.3
2020-11
0
2.14
2020-12
0
2.17
2021-01
0
2.28
2021-02
0
1.91
2021-03
0
1.92
2021-04
1
1.92
2021-05
0
1.89
2021-06
0
2.31
2021-07
0
2.15
2021-08
0
2.1
2021-09
1
2.23
2021-10
0
2.06
2021-11
0
1.93
2021-12
0
2.13
2022-01
0
1.93
2022-02
0
1.94
2022-03
1
1.98
2022-04
1
2.01
2022-05
0
1.99
2022-06
0
2.07
2022-07
0
1.95
2022-08
0
2
2022-09
0
2.03
2022-10
0
1.99
2022-11
1
2.06
2022-12
0
2
2023-01
0
2.09
2023-02
0
1.95
2023-03
0
2.15
2023-04
0
2.08
2023-05
0
2.03
2023-06
1
2.07
2023-07
1
1.96
2023-08
0
1.84
2023-09
0
1.86
2023-10
1
1.57
2023-11
1
1.53
2023-12
0
1.63
2024-01
1
1.66
2024-02
0
1.91
2024-03
0
1.86
2024-04
0
1.67
2024-05
0
1.94
2024-06
0
1.8
2024-07
0
1.65
2024-08
0
1.79
2024-09
0
1.88
2024-10
2
1.7
2024-11
1
1.65
2024-12
1
1.5
2025-01
1
1.8
2025-02
1
1.47
2025-03
0
1.76
2025-04
1
1.76
2025-05
2
1.63
2025-06
3
1.78
2025-07
3
1.76
2025-08
3
1.61
2025-09
4
1.67
2025-10
3
1.67
2025-11
1
1.74
2025-12
2
1.84
2026-01
4
1.89
2026-02
1
1.57
2026-03
1
1.87
2026-04
9
1.84
2026-05
3
1.6
2026-06
4
1.66
This device (reports/month)Average device in JDI, KWL, KWY, KWZ, LPH, LZO, MEH, OQG (reports/device/month)
Failure-mode summaryAI-generated
40 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.