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.
211 linked reportsInjury 211
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
7
2.58
2019-02
4
2.2
2019-03
8
2.34
2019-04
6
2.33
2019-05
2
1.91
2019-06
6
1.65
2019-07
4
1.73
2019-08
6
1.9
2019-09
7
1.97
2019-10
3
2.11
2019-11
3
1.69
2019-12
2
1.96
2020-01
3
2.17
2020-02
1
2.16
2020-03
1
2.7
2020-04
5
1.87
2020-05
1
1.97
2020-06
3
1.7
2020-07
3
2.13
2020-08
3
1.63
2020-09
1
1.84
2020-10
4
1.97
2020-11
4
1.88
2020-12
0
1.94
2021-01
0
1.98
2021-02
1
1.7
2021-03
2
1.76
2021-04
4
1.66
2021-05
2
1.64
2021-06
4
2.05
2021-07
3
1.88
2021-08
2
1.77
2021-09
2
1.9
2021-10
3
1.8
2021-11
5
1.76
2021-12
4
1.95
2022-01
2
1.64
2022-02
1
1.94
2022-03
0
1.68
2022-04
1
1.85
2022-05
1
1.75
2022-06
2
1.8
2022-07
3
1.77
2022-08
2
1.9
2022-09
2
1.84
2022-10
2
1.78
2022-11
0
1.88
2022-12
2
1.73
2023-01
1
1.93
2023-02
3
1.75
2023-03
0
1.8
2023-04
1
1.86
2023-05
4
1.89
2023-06
4
1.94
2023-07
1
1.96
2023-08
1
1.91
2023-09
1
1.94
2023-10
4
1.48
2023-11
1
1.48
2023-12
0
1.51
2024-01
2
1.61
2024-02
0
1.74
2024-03
6
1.95
2024-04
3
1.62
2024-05
1
2.09
2024-06
4
1.85
2024-07
2
1.61
2024-08
1
1.84
2024-09
0
1.93
2024-10
0
1.6
2024-11
4
1.44
2024-12
2
1.46
2025-01
9
1.52
2025-02
2
1.38
2025-03
2
1.67
2025-04
1
1.69
2025-05
0
1.39
2025-06
0
1.63
2025-07
2
1.65
2025-08
1
1.44
2025-09
2
1.63
2025-10
1
1.64
2025-11
3
1.7
2025-12
1
1.69
2026-01
0
1.84
2026-02
2
1.46
2026-03
1
1.91
2026-04
1
1.65
2026-05
0
1.59
2026-06
0
1.56
This device (reports/month)Average device in JDI, KWY, LWJ (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
2026-04-21
0002249697-2026-00318
Injury
Available
exact di
2026-03-17
0002249697-2026-00181
Injury
Available
exact di
2026-02-24
0002249697-2026-00116
Injury
Available
exact di
2026-02-10
0002249697-2026-00089
Injury
Available
exact di
2025-12-12
0002249697-2025-01462
Injury
Available
exact di
2025-11-20
0002249697-2025-01356
Injury
Available
exact di
2025-11-12
0002249697-2025-01317
Injury
Available
exact di
2025-11-05
0002249697-2025-01304
Injury
Available
exact di
2025-10-22
0002249697-2025-01159
Injury
Available
exact di
2025-09-11
0002249697-2025-00973
Injury
Available
exact di
2025-09-04
0002249697-2025-00947
Injury
Available
exact di
2025-08-06
0002249697-2025-00837
Injury
Available
exact di
2025-07-31
0002249697-2025-00754
Injury
Available
exact di
2025-07-28
0002249697-2025-00732
Injury
Available
exact di
2025-04-07
0002249697-2025-00382
Injury
Available
exact di
Showing the most recent 200 of 211 linked reports.