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Adverse-event reports (MAUDE)

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.

3 linked reportsMalfunction 3
13452019-01: 0 reports for this device; peer average 2.35/device2019-02: 0 reports for this device; peer average 2.67/device2019-03: 0 reports for this device; peer average 2.43/device2019-04: 0 reports for this device; peer average 2.37/device2019-05: 0 reports for this device; peer average 2.65/device2019-06: 0 reports for this device; peer average 2.56/device2019-07: 0 reports for this device; peer average 2.16/device2019-08: 0 reports for this device; peer average 2.83/device2019-09: 0 reports for this device; peer average 2.25/device2019-10: 0 reports for this device; peer average 2.63/device2019-11: 0 reports for this device; peer average 3.44/device2019-12: 0 reports for this device; peer average 2.24/device2020-01: 0 reports for this device; peer average 2.8/device2020-02: 0 reports for this device; peer average 3.26/device2020-03: 0 reports for this device; peer average 3.02/device2020-04: 0 reports for this device; peer average 3.8/device2020-05: 0 reports for this device; peer average 2.41/device2020-06: 0 reports for this device; peer average 2.32/device2020-07: 0 reports for this device; peer average 2.53/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.79/device2020-10: 0 reports for this device; peer average 3.93/device2020-11: 0 reports for this device; peer average 3.28/device2020-12: 0 reports for this device; peer average 2.79/device2021-01: 0 reports for this device; peer average 3.16/device2021-02: 0 reports for this device; peer average 2.67/device2021-03: 0 reports for this device; peer average 2.89/device2021-04: 0 reports for this device; peer average 2.79/device2021-05: 0 reports for this device; peer average 2.9/device2021-06: 0 reports for this device; peer average 2.78/device2021-07: 0 reports for this device; peer average 4.68/device2021-08: 0 reports for this device; peer average 2.23/device2021-09: 0 reports for this device; peer average 2.16/device2021-10: 0 reports for this device; peer average 2.36/device2021-11: 0 reports for this device; peer average 2.62/device2021-12: 0 reports for this device; peer average 2.41/device2022-01: 0 reports for this device; peer average 2.28/device2022-02: 0 reports for this device; peer average 2.41/device2022-03: 0 reports for this device; peer average 2.33/device2022-04: 0 reports for this device; peer average 2.18/device2022-05: 0 reports for this device; peer average 2.73/device2022-06: 0 reports for this device; peer average 2.92/device2022-07: 0 reports for this device; peer average 3.83/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.58/device2022-10: 0 reports for this device; peer average 2.25/device2022-11: 0 reports for this device; peer average 2.35/device2022-12: 0 reports for this device; peer average 2.85/device2023-01: 0 reports for this device; peer average 2.36/device2023-02: 0 reports for this device; peer average 2.48/device2023-03: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 2.44/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.02/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 2.06/device2023-09: 0 reports for this device; peer average 3.21/device2023-10: 0 reports for this device; peer average 2.84/device2023-11: 0 reports for this device; peer average 5.05/device2023-12: 0 reports for this device; peer average 2.84/device2024-01: 0 reports for this device; peer average 2.65/device2024-02: 0 reports for this device; peer average 3.04/device2024-03: 0 reports for this device; peer average 3.77/device2024-04: 0 reports for this device; peer average 2.48/device2024-05: 0 reports for this device; peer average 3.96/device2024-06: 0 reports for this device; peer average 3.25/device2024-07: 0 reports for this device; peer average 2.67/device2024-08: 0 reports for this device; peer average 2.85/device2024-09: 0 reports for this device; peer average 3.65/device2024-10: 0 reports for this device; peer average 3.9/device2024-11: 0 reports for this device; peer average 3.21/device2024-12: 0 reports for this device; peer average 2.78/device2025-01: 0 reports for this device; peer average 5.1/device2025-02: 0 reports for this device; peer average 3.33/device2025-03: 0 reports for this device; peer average 2.81/device2025-04: 0 reports for this device; peer average 3.1/device2025-05: 0 reports for this device; peer average 3.34/device2025-06: 3 reports for this device; peer average 3.16/device2025-07: 0 reports for this device; peer average 2.91/device2025-08: 0 reports for this device; peer average 3.43/device2025-09: 0 reports for this device; peer average 2.72/device2025-10: 0 reports for this device; peer average 2.99/device2025-11: 0 reports for this device; peer average 2.92/device2025-12: 0 reports for this device; peer average 3.47/device2026-01: 0 reports for this device; peer average 3.3/device2026-02: 0 reports for this device; peer average 3.13/device2026-03: 0 reports for this device; peer average 3.1/device2026-04: 0 reports for this device; peer average 2.82/device2026-05: 0 reports for this device; peer average 3.53/device2026-06: 0 reports for this device; peer average 4.02/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.35
2019-0202.67
2019-0302.43
2019-0402.37
2019-0502.65
2019-0602.56
2019-0702.16
2019-0802.83
2019-0902.25
2019-1002.63
2019-1103.44
2019-1202.24
2020-0102.8
2020-0203.26
2020-0303.02
2020-0403.8
2020-0502.41
2020-0602.32
2020-0702.53
2020-0802.21
2020-0902.79
2020-1003.93
2020-1103.28
2020-1202.79
2021-0103.16
2021-0202.67
2021-0302.89
2021-0402.79
2021-0502.9
2021-0602.78
2021-0704.68
2021-0802.23
2021-0902.16
2021-1002.36
2021-1102.62
2021-1202.41
2022-0102.28
2022-0202.41
2022-0302.33
2022-0402.18
2022-0502.73
2022-0602.92
2022-0703.83
2022-0802.24
2022-0902.58
2022-1002.25
2022-1102.35
2022-1202.85
2023-0102.36
2023-0202.48
2023-0302.5
2023-0402.44
2023-0502.1
2023-0602.02
2023-0702.22
2023-0802.06
2023-0903.21
2023-1002.84
2023-1105.05
2023-1202.84
2024-0102.65
2024-0203.04
2024-0303.77
2024-0402.48
2024-0503.96
2024-0603.25
2024-0702.67
2024-0802.85
2024-0903.65
2024-1003.9
2024-1103.21
2024-1202.78
2025-0105.1
2025-0203.33
2025-0302.81
2025-0403.1
2025-0503.34
2025-0633.16
2025-0702.91
2025-0803.43
2025-0902.72
2025-1002.99
2025-1102.92
2025-1203.47
2026-0103.3
2026-0203.13
2026-0303.1
2026-0402.82
2026-0503.53
2026-0604.02
This device (reports/month)Average device in KWP, NKB, OLO, OWL (reports/device/month)
Failure-mode summaryAI-generated

3 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-06-183015941638-2025-00005MalfunctionAvailablecatalog number

Showing the most recent 1 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-04-23VAIVoluntary action indicatedAstura Medical5
2026-04-23VAIVoluntary action indicatedAstura Medical5
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