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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.

2 linked reportsMalfunction 2
11222019-06: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-09: 2 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device060801020910110710111201050710
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0602
2019-0802
2021-0101
2022-0201
2022-0922
2022-1002
2022-1101
2023-0702
2023-1002
2023-1101
2024-1202
2025-0101
2025-0501
2025-0701
2025-1001
This device (reports/month)Average device in GZX (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2022-09-2715492235MalfunctionAvailablecatalog number

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-08-15NAINo action indicatedScanlan International, Inc.0
2019-08-15NAINo action indicatedScanlan International, Inc.0
2016-02-03NAINo action indicatedScanlan International, Inc.0
2016-02-03NAINo action indicatedScanlan International, Inc.0
2012-10-17NAINo action indicatedScanlan International, Inc.0
2012-10-17NAINo action indicatedScanlan International, Inc.0
2010-06-22NAINo action indicatedScanlan International, Inc.0
2010-06-22NAINo action indicatedScanlan International, Inc.0
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