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.
353 linked reportsMalfunction 229Injury 124
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
2.15
2019-02
1
2.14
2019-03
2
1.93
2019-04
5
2.11
2019-05
0
2.3
2019-06
0
2.57
2019-07
0
1.67
2019-08
0
3
2019-09
2
1.75
2019-10
2
1.92
2019-11
14
2.44
2019-12
2
1.59
2020-01
0
2.43
2020-02
7
2.23
2020-03
10
2.38
2020-04
0
1.6
2020-05
20
2.71
2020-06
5
1.75
2020-07
18
2.06
2020-08
4
2.08
2020-09
22
2.52
2020-10
7
2.75
2020-11
1
2.36
2020-12
4
1.97
2021-01
0
2.4
2021-02
0
1.89
2021-03
10
2.61
2021-04
2
2.4
2021-05
6
2
2021-06
5
2.4
2021-07
8
2.27
2021-08
0
2.02
2021-09
1
1.95
2021-10
8
2.57
2021-11
1
2.35
2021-12
13
2.54
2022-01
0
2.18
2022-02
0
2.12
2022-03
0
1.9
2022-04
0
2.06
2022-05
0
1.9
2022-06
5
2.09
2022-07
76
4.92
2022-08
1
1.8
2022-09
1
2.66
2022-10
6
1.61
2022-11
0
1.8
2022-12
6
2.27
2023-01
0
1.97
2023-02
2
1.85
2023-03
1
1.64
2023-04
3
1.92
2023-05
0
1.56
2023-06
0
1.75
2023-07
0
2.05
2023-08
3
2.22
2023-09
0
2.61
2023-10
0
2.69
2023-11
0
2.46
2023-12
0
1.74
2024-01
1
2.44
2024-02
0
2.29
2024-03
0
3.6
2024-04
0
1.7
2024-05
0
3.68
2024-06
0
3.14
2024-07
0
1.96
2024-08
0
2
2024-09
51
3.67
2024-10
0
2.27
2024-11
0
2.18
2024-12
0
2.1
2025-01
1
2.32
2025-02
5
2.66
2025-03
0
2.4
2025-04
5
2.39
2025-05
0
2.64
2025-06
0
2.25
2025-07
0
1.9
2025-08
0
2.02
2025-09
0
1.81
2025-10
0
1.81
2025-11
3
2.03
2025-12
0
2.7
2026-01
0
2.28
2026-02
0
2.42
2026-03
0
2.37
2026-04
0
1.94
2026-05
0
2.28
2026-06
2
3.87
This device (reports/month)Average device in NKB (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
2026-06-09
1526439-2026-00694
Malfunction
Available
exact di
2026-06-09
1526439-2026-00696
Malfunction
Available
exact di
2025-11-21
1526439-2025-01549
Malfunction
Available
exact di
2025-11-21
1526439-2025-01552
Malfunction
Available
exact di
2025-11-21
1526439-2025-01551
Malfunction
Available
exact di
2025-04-30
1526439-2025-00557
Malfunction
Available
exact di
2025-04-03
1526439-2025-00448
Malfunction
Available
exact di
2025-04-03
1526439-2025-00449
Malfunction
Available
exact di
2025-04-03
1526439-2025-00446
Malfunction
Available
exact di
2025-04-03
1526439-2025-00447
Malfunction
Available
exact di
2025-02-25
1526439-2025-00299
Malfunction
Available
exact di
2025-02-25
1526439-2025-00294
Malfunction
Available
exact di
2025-02-25
1526439-2025-00295
Malfunction
Available
exact di
2025-02-25
1526439-2025-00298
Malfunction
Available
exact di
2025-02-25
1526439-2025-00297
Malfunction
Available
exact di
Showing the most recent 200 of 353 linked reports.