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.
465 linked reportsMalfunction 418Injury 47
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
2.23
2019-02
5
2.95
2019-03
10
1.95
2019-04
3
2.54
2019-05
2
2.58
2019-06
3
2.13
2019-07
5
2.88
2019-08
3
2.31
2019-09
2
2.59
2019-10
5
3.55
2019-11
4
2.61
2019-12
6
3.08
2020-01
8
2.65
2020-02
3
2.14
2020-03
0
2.57
2020-04
0
2.06
2020-05
3
2.2
2020-06
7
2.79
2020-07
4
3.4
2020-08
5
3.22
2020-09
2
3.04
2020-10
3
3.82
2020-11
9
4.24
2020-12
4
3.5
2021-01
4
4.53
2021-02
6
3.6
2021-03
7
3.73
2021-04
4
3.42
2021-05
6
3.39
2021-06
3
3.09
2021-07
1
3.34
2021-08
1
2.55
2021-09
4
3.23
2021-10
8
2.68
2021-11
3
3.38
2021-12
1
3.64
2022-01
4
3.69
2022-02
5
3.36
2022-03
11
3.02
2022-04
5
3.35
2022-05
5
2.79
2022-06
5
2.88
2022-07
5
3.37
2022-08
7
3.33
2022-09
12
4.38
2022-10
5
2.97
2022-11
2
3.63
2022-12
10
3.15
2023-01
7
3.5
2023-02
8
3.32
2023-03
7
3.94
2023-04
0
3.01
2023-05
5
4.21
2023-06
9
3.57
2023-07
4
3.65
2023-08
8
2.96
2023-09
14
2.53
2023-10
17
2.7
2023-11
11
2.46
2023-12
10
2.32
2024-01
19
2.51
2024-02
1
2.89
2024-03
6
2.61
2024-04
5
2.38
2024-05
5
3.31
2024-06
3
3
2024-07
6
3.19
2024-08
3
2.25
2024-09
9
3.85
2024-10
4
2.67
2024-11
2
2.56
2024-12
3
1.94
2025-01
3
5.71
2025-02
20
4.27
2025-03
2
2.71
2025-04
3
2.89
2025-05
21
3.18
2025-06
5
2.74
2025-07
4
2.97
2025-08
0
3.06
2025-09
2
2.47
2025-10
2
2.19
2025-11
3
2.86
2025-12
0
3.46
2026-01
1
3.06
2026-02
4
2.46
2026-03
1
2.72
2026-04
3
2.96
2026-05
1
2.98
2026-06
0
3.27
This device (reports/month)Average device in HXX (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
2026-05-04
1526439-2026-00516
Malfunction
Available
exact di
2026-04-15
1526439-2026-00385
Malfunction
Available
exact di
2026-04-15
1526439-2026-00370
Malfunction
Available
exact di
2026-04-10
1526439-2026-00353
Malfunction
Available
exact di
2026-03-11
1526439-2026-00245
Malfunction
Available
exact di
2026-02-18
1526439-2026-00172
Malfunction
Available
exact di
2026-02-18
1526439-2026-00183
Malfunction
Available
exact di
2026-02-18
1526439-2026-00184
Malfunction
Available
exact di
2026-02-18
1526439-2026-00173
Malfunction
Available
exact di
2026-01-27
1526439-2026-00073
Malfunction
Available
exact di
2025-11-17
1526439-2025-01509
Malfunction
Available
exact di
2025-11-03
1526439-2025-01400
Malfunction
Available
exact di
2025-11-03
1526439-2025-01401
Malfunction
Available
exact di
2025-10-15
1526439-2025-01300
Malfunction
Available
exact di
2025-10-15
1526439-2025-01301
Malfunction
Available
exact di
Showing the most recent 200 of 465 linked reports.