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.
137 linked reportsInjury 72Malfunction 65
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
9.36
2019-02
0
8.88
2019-03
0
9.49
2019-04
0
10.01
2019-05
0
8.46
2019-06
1
10.16
2019-07
1
10.28
2019-08
4
8.6
2019-09
0
8.99
2019-10
0
8.74
2019-11
0
9.01
2019-12
2
9.63
2020-01
0
9.4
2020-02
0
8.78
2020-03
0
9.01
2020-04
1
7.84
2020-05
0
7.14
2020-06
0
9.22
2020-07
7
9.85
2020-08
1
9.3
2020-09
1
10.38
2020-10
2
10.25
2020-11
4
10.04
2020-12
8
10.94
2021-01
2
9.17
2021-02
0
9.12
2021-03
4
9.2
2021-04
1
10.51
2021-05
0
9.87
2021-06
0
9.36
2021-07
0
9.47
2021-08
1
12.13
2021-09
0
10.54
2021-10
10
10.3
2021-11
0
8.66
2021-12
0
10.87
2022-01
0
8.99
2022-02
0
8.82
2022-03
0
9.63
2022-04
0
9.6
2022-05
0
9.67
2022-06
0
10.48
2022-07
1
9.74
2022-08
0
10.43
2022-09
6
9.46
2022-10
0
10.42
2022-11
1
10.65
2022-12
3
10.24
2023-01
0
10.22
2023-02
0
10.09
2023-03
1
12.95
2023-04
0
10.28
2023-05
2
10.03
2023-06
0
11.45
2023-07
0
11.13
2023-08
0
8.77
2023-09
0
8.35
2023-10
4
8.5
2023-11
16
8.45
2023-12
2
9.15
2024-01
0
9.83
2024-02
1
9.62
2024-03
0
7.87
2024-04
0
8.7
2024-05
1
7.29
2024-06
0
8.32
2024-07
0
8.4
2024-08
1
7.49
2024-09
0
10.03
2024-10
1
8.35
2024-11
0
9.75
2024-12
0
7.46
2025-01
2
8.67
2025-02
4
7.42
2025-03
0
7.21
2025-04
4
6.82
2025-05
0
8.99
2025-06
0
8.25
2025-07
0
10.67
2025-08
0
8.77
2025-09
2
8.91
2025-10
8
8.3
2025-11
0
8.75
2025-12
0
10.1
2026-01
14
9.42
2026-02
0
9.15
2026-03
13
9.37
2026-04
0
9.23
2026-05
0
7.84
2026-06
0
10.14
This device (reports/month)Average device in GDW, QQS (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
2026-03-26
1216677-2026-00025
Injury
Available
exact di
2026-03-25
1216677-2026-00024
Injury
Available
exact di
2026-03-10
1216677-2026-00019
Injury
Available
exact di
2026-03-10
1216677-2026-00017
Injury
Available
exact di
2026-03-10
1216677-2026-00018
Injury
Available
exact di
2026-03-10
1216677-2026-00020
Injury
Available
exact di
2026-01-29
1216677-2026-00008
Injury
Available
exact di
2026-01-29
1216677-2026-00007
Injury
Available
exact di
2026-01-29
MW5183040
Injury
Available
model number
2026-01-29
1216677-2026-00005
Injury
Available
exact di
2026-01-28
1216677-2026-00004
Injury
Available
exact di
2026-01-22
MW5182634
Injury
Available
model number
2025-10-21
1216677-2025-00047
Injury
Available
exact di
2025-10-21
1216677-2025-00046
Injury
Available
exact di
2025-10-21
1216677-2025-00044
Injury
Available
exact di
Showing the most recent 100 of 137 linked reports.