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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.

6 linked reportsMalfunction 5Injury 1
12342019-03: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 4/device2019-09: 0 reports for this device; peer average 1/device2019-12: 1 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 2/device2020-07: 1 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 3/device2021-11: 1 reports for this device; peer average 1/device2022-07: 1 reports for this device; peer average 1/device2023-04: 2 reports for this device; peer average 1.8/device2023-05: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device03050912010607121107040504011006
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301
2019-0504
2019-0901
2019-1211
2020-0103
2020-0602
2020-0711
2020-1203
2021-1111
2022-0711
2023-0421.8
2023-0501.75
2024-0401
2025-0101
2025-1001
2026-0601
This device (reports/month)Average device in JEC (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-04-063025141-2023-00114MalfunctionAvailablemodel number
2023-04-063025141-2023-00113MalfunctionAvailablemodel number
2022-07-193025141-2022-00226MalfunctionAvailablemodel number
2021-11-013025141-2021-00111MalfunctionAvailablemodel number
2020-07-213025141-2020-00160InjuryAvailablemodel number
2019-12-183025141-2019-00635MalfunctionAvailablemodel number
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2017-05-11VAIVoluntary action indicatedAcumed LLC4
2017-05-11VAIVoluntary action indicatedAcumed LLC4
2013-06-26NAINo action indicatedAcumed LLC0
2013-06-26NAINo action indicatedAcumed LLC0
2011-07-27NAINo action indicatedAcumed LLC0
2011-07-27NAINo action indicatedAcumed LLC0
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