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.
339 linked reportsMalfunction 331Injury 8
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
8
2.75
2019-02
3
3
2019-03
8
4.67
2019-04
7
2.44
2019-05
22
22
2019-06
24
4.25
2019-07
8
6
2019-08
7
7
2019-09
3
2.2
2019-10
4
1.75
2019-11
2
1.25
2019-12
9
5
2020-01
2
1.5
2020-02
6
2.4
2020-03
6
6
2020-04
2
1.5
2020-05
2
2
2020-06
8
2.4
2020-07
7
3
2020-08
9
5
2020-09
2
1.33
2020-10
6
6
2020-11
1
1.5
2020-12
7
5
2021-01
4
3
2021-02
5
4.5
2021-03
9
8
2021-04
7
5.33
2021-05
2
10.5
2021-06
7
5
2021-07
3
6.67
2021-08
5
5.6
2021-09
5
3.2
2021-10
3
3
2021-11
1
3
2021-12
4
3.67
2022-01
3
2.5
2022-02
2
3.75
2022-03
6
4.5
2022-04
2
3
2022-05
1
4.5
2022-06
4
2.89
2022-07
4
3.75
2022-08
1
3
2022-09
0
2.33
2022-10
3
5.5
2022-11
5
5.2
2022-12
3
2.25
2023-01
2
4.83
2023-02
1
2.67
2023-03
4
3.11
2023-04
2
3.5
2023-05
3
5.17
2023-06
0
3
2023-07
1
3.5
2023-08
2
3.8
2023-09
6
2.89
2023-10
1
2.5
2023-11
1
2.89
2023-12
3
4.11
2024-01
0
2
2024-02
4
3.25
2024-03
2
2.7
2024-04
3
4.09
2024-05
1
2.73
2024-06
2
2.33
2024-07
5
3
2024-08
1
6.67
2024-09
1
2
2024-10
7
4.6
2024-11
4
4.83
2024-12
3
3.8
2025-01
4
1.92
2025-02
7
4.65
2025-03
2
3.43
2025-04
1
1.93
2025-05
2
5.67
2025-06
0
8.5
2025-07
2
1.75
2025-08
1
4
2025-09
1
3
2025-10
0
2.4
2025-11
2
4.5
2025-12
1
2
2026-01
4
2.1
2026-02
0
2.33
2026-03
1
6.5
2026-04
0
1.38
2026-05
0
3
2026-06
0
2
This device (reports/month)Average device in PGW (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
2026-03-02
1723170-2026-00332
Malfunction
Available
model number
2026-01-26
1723170-2026-00142
Malfunction
Available
exact di
2026-01-08
1723170-2026-00045
Malfunction
Available
exact di
2025-12-01
1723170-2025-03837
Malfunction
Available
model number
2025-11-26
1723170-2025-03818
Malfunction
Available
exact di
2025-09-18
1723170-2025-03261
Malfunction
Available
model number
2025-08-25
1723170-2025-03055
Malfunction
Available
model number
2025-07-02
1723170-2025-02580
Malfunction
Available
exact di
2025-05-15
1723170-2025-01969
Malfunction
Available
model number
2025-05-08
1723170-2025-01905
Malfunction
Available
model number
2025-04-01
1723170-2025-01512
Malfunction
Available
model number
2025-03-25
1723170-2025-01457
Malfunction
Available
model number
2025-03-17
1723170-2025-01334
Malfunction
Available
model number
2025-02-26
1723170-2025-01004
Malfunction
Available
model number
2025-02-26
1723170-2025-01000
Malfunction
Available
model number
Showing the most recent 200 of 339 linked reports.
Showing 1–15 of 200
Regulatory clearances
510(k)K153247Substantially equivalent (SESE) · 2016-02-18clearance family
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.