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.
286 linked reportsMalfunction 285Injury 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
1
2.33
2019-02
0
1.53
2019-03
0
2.33
2019-04
0
2.14
2019-05
0
2.28
2019-06
0
2.4
2019-07
0
1.92
2019-08
0
2.5
2019-09
0
3.42
2019-10
8
2.26
2019-11
1
1.86
2019-12
0
2.2
2020-01
9
3.07
2020-02
1
2.29
2020-03
2
2.4
2020-04
0
1.75
2020-05
0
1.67
2020-06
0
2.95
2020-07
1
2.33
2020-08
1
2.7
2020-09
2
2.59
2020-10
4
2.84
2020-11
3
2.83
2020-12
5
2.62
2021-01
2
3.19
2021-02
2
2.67
2021-03
5
2.87
2021-04
5
3.2
2021-05
0
2.67
2021-06
4
2.46
2021-07
1
2.4
2021-08
1
2.05
2021-09
0
2.9
2021-10
4
2.62
2021-11
2
2.63
2021-12
5
2
2022-01
3
2.63
2022-02
2
1.65
2022-03
4
2.41
2022-04
2
2.59
2022-05
2
2.73
2022-06
2
1.89
2022-07
2
2.29
2022-08
3
2.4
2022-09
3
2.17
2022-10
1
2.47
2022-11
0
2.32
2022-12
1
3.59
2023-01
5
2.25
2023-02
2
3.1
2023-03
6
2.81
2023-04
5
2
2023-05
4
4.46
2023-06
3
3.52
2023-07
3
3.38
2023-08
2
2.3
2023-09
5
3.46
2023-10
3
2.64
2023-11
3
3.76
2023-12
8
3.56
2024-01
7
2.48
2024-02
0
2.73
2024-03
11
2.95
2024-04
2
2.32
2024-05
4
4.15
2024-06
6
5.53
2024-07
3
3.14
2024-08
5
2.3
2024-09
8
2.76
2024-10
4
2.61
2024-11
7
2.5
2024-12
2
2.7
2025-01
7
3.35
2025-02
4
3.62
2025-03
2
3.11
2025-04
6
3
2025-05
1
3
2025-06
2
2.44
2025-07
2
2.88
2025-08
2
2.84
2025-09
1
1.89
2025-10
2
3
2025-11
4
2.94
2025-12
7
3.71
2026-01
6
2.45
2026-02
4
3.21
2026-03
3
2.39
2026-04
8
2.57
2026-05
20
3.8
2026-06
3
2.86
This device (reports/month)Average device in NBH (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
2026-06-26
1221934-2026-02806
Malfunction
—
exact di
2026-06-15
1221934-2026-02591
Malfunction
Available
exact di
2026-06-08
1221934-2026-02438
Malfunction
Available
exact di
2026-05-29
1221934-2026-02335
Malfunction
Available
exact di
2026-05-29
1221934-2026-02316
Malfunction
Available
exact di
2026-05-26
1221934-2026-02195
Malfunction
Available
exact di
2026-05-26
1221934-2026-02177
Malfunction
Available
exact di
2026-05-21
1221934-2026-02138
Malfunction
Available
exact di
2026-05-21
1221934-2026-02132
Malfunction
Available
exact di
2026-05-21
1221934-2026-02143
Malfunction
Available
exact di
2026-05-21
1221934-2026-02146
Malfunction
Available
exact di
2026-05-21
1221934-2026-02133
Malfunction
Available
exact di
2026-05-21
1221934-2026-02144
Malfunction
Available
exact di
2026-05-19
1221934-2026-02104
Malfunction
Available
exact di
2026-05-15
1221934-2026-02056
Malfunction
Available
exact di
Showing the most recent 200 of 286 linked reports.