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.
31 linked reportsMalfunction 30Death 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
0
2
2019-02
0
4
2019-03
0
3
2019-04
0
6.5
2019-05
2
2.33
2019-06
2
4.25
2019-07
0
2
2019-08
2
2
2019-09
0
4
2019-10
2
2.4
2019-11
2
2
2019-12
2
1.8
2020-01
0
1.5
2020-02
0
1.5
2020-03
0
2.33
2020-04
2
2
2020-05
0
1.33
2020-07
0
2
2020-08
2
1.67
2020-09
0
1.5
2020-10
0
2.2
2020-11
0
1
2020-12
0
2
2021-02
0
7
2021-03
2
6.67
2021-04
0
3
2021-05
0
2.5
2021-06
2
12.25
2021-07
0
22.5
2021-08
0
16.5
2021-09
0
8.5
2021-10
0
30
2021-11
0
22
2021-12
2
11.75
2022-01
0
12.67
2022-02
0
9
2022-03
0
34
2022-04
6
3.25
2022-05
0
3
2022-06
0
1.67
2022-07
0
3
2022-08
0
2
2022-09
0
4
2022-10
0
2
2022-11
0
2
2022-12
0
2
2023-02
0
2.67
2023-03
0
3
2023-04
0
2
2023-05
2
2.33
2023-06
0
2.5
2023-07
0
3
2023-08
1
1.67
2023-09
0
2.75
2023-10
0
2
2023-11
0
3
2023-12
0
2.33
2024-01
0
3.5
2024-02
0
3.5
2024-03
0
2
2024-04
0
3.25
2024-05
0
2
2024-06
0
2.33
2024-07
0
3.5
2024-08
0
1.67
2024-09
0
1.5
2024-10
0
5
2024-11
0
6.67
2024-12
0
4
2025-01
0
1.6
2025-02
0
3.5
2025-03
0
3
2025-04
0
1
2025-05
0
3
2025-06
0
1.8
2025-07
0
5
2025-09
0
1.5
2025-10
0
2.83
2025-11
0
3
2025-12
0
2
2026-01
0
2
2026-02
0
2.5
2026-03
0
3.2
2026-04
0
2
2026-05
0
1.25
2026-06
0
3.83
This device (reports/month)Average device in HIG (reports/device/month)
Failure-mode summaryAI-generated
31 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2023-08-18
3002914049-2023-00007
Death
Available
model number
2023-05-17
3002914049-2023-00003
Malfunction
Available
exact di
2022-04-28
3002914049-2022-00003
Malfunction
Available
exact di
2022-04-13
3002914049-2022-00002
Malfunction
Available
exact di
2022-04-07
3002914049-2022-00001
Malfunction
Available
exact di
2021-12-08
3002914049-2021-00007
Malfunction
Available
exact di
2021-06-21
3002914049-2021-00006
Malfunction
Available
exact di
2021-03-10
3002914049-2021-00001
Malfunction
Available
exact di
2020-08-12
3002914049-2020-00006
Malfunction
Available
exact di
2020-04-09
3002914049-2020-00004
Malfunction
Available
exact di
2019-12-13
3002914049-2019-00018
Malfunction
Available
exact di
2019-11-08
3002914049-2019-00016
Malfunction
Available
exact di
2019-10-11
3002914049-2019-00014
Malfunction
Available
exact di
2019-08-09
3002914049-2019-00009
Malfunction
Available
exact di
2019-06-12
3002914049-2019-00005
Malfunction
Available
exact di
Showing the most recent 16 of 31 linked reports.
Showing 1–15 of 16
Regulatory clearances
510(k)K112642Substantially equivalent (SESE) · 2012-02-06clearance 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.