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.
352 linked reportsMalfunction 352
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
3
2019-03
1
1
2019-04
2
2
2019-05
2
2
2019-06
0
2
2019-07
1
1
2019-09
6
2
2019-10
9
9
2019-11
0
1
2019-12
1
1
2020-01
2
1.5
2020-02
2
2
2020-03
5
3
2020-05
4
4
2020-06
1
1
2020-07
7
4
2020-08
1
1
2020-09
1
1
2020-10
3
2.67
2020-11
5
3
2020-12
7
7
2021-01
3
3
2021-02
3
2
2021-03
7
4.5
2021-04
3
3.75
2021-05
4
4
2021-06
7
4
2021-07
5
5
2021-08
2
2
2021-09
2
2
2021-10
3
2.5
2021-11
2
2
2021-12
1
1
2022-01
4
2
2022-02
3
2
2022-03
1
1.5
2022-04
6
3.5
2022-05
4
4
2022-06
6
6
2022-07
5
2.67
2022-08
10
5.5
2022-09
4
2.33
2022-10
6
6
2022-11
7
7
2022-12
6
6
2023-01
5
5
2023-02
2
2
2023-03
5
3
2023-04
4
4
2023-05
8
8
2023-06
5
5
2023-07
4
4
2023-08
5
3
2023-09
1
1
2023-10
7
4
2023-11
3
3
2023-12
2
2
2024-01
3
2
2024-02
5
3
2024-03
4
4
2024-04
4
4
2024-05
2
2
2024-06
15
15
2024-07
14
14
2024-08
9
5.5
2024-09
5
5
2024-10
6
6
2024-11
3
3
2024-12
3
2
2025-01
6
6
2025-02
2
1.5
2025-03
7
7
2025-04
2
2
2025-06
8
8
2025-07
10
10
2025-08
5
5
2025-09
2
2
2025-10
2
2
2025-11
2
2
2025-12
3
3
2026-02
1
1
2026-03
5
3
2026-04
2
1.5
2026-05
1
1
2026-06
2
2
This device (reports/month)Average device in FZT (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
2026-06-30
1221934-2026-02853
Malfunction
—
exact di
2026-06-01
1221934-2026-02352
Malfunction
Available
exact di
2026-05-26
1221934-2026-02162
Malfunction
Available
exact di
2026-04-21
1221934-2026-01594
Malfunction
Available
exact di
2026-04-21
1221934-2026-01595
Malfunction
Available
exact di
2026-03-25
1221934-2026-01225
Malfunction
Available
exact di
2026-03-24
1221934-2026-01215
Malfunction
Available
exact di
2026-03-16
1221934-2026-01077
Malfunction
Available
exact di
2026-03-12
1221934-2026-01051
Malfunction
Available
exact di
2026-03-02
1221934-2026-00935
Malfunction
Available
exact di
2026-02-25
1221934-2026-00891
Malfunction
Available
exact di
2025-12-17
1221934-2025-04850
Malfunction
Available
exact di
2025-12-15
1221934-2025-04762
Malfunction
Available
exact di
2025-12-04
1221934-2025-04611
Malfunction
Available
exact di
2025-11-24
1221934-2025-04513
Malfunction
Available
exact di
Showing the most recent 200 of 352 linked reports.