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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
01112023-07: 1 reports for this device; peer average 1/device2023-09: 1 reports for this device; peer average 1/device0709
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0711
2023-0911
This device (reports/month)Average device in LZU (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
2023-09-261018233-2023-07080MalfunctionAvailableexact di
2023-07-191018233-2023-05278MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2016-08-31NAINo action indicatedKatena Products, Inc.0
2014-04-21NAINo action indicatedKatena Products Inc.0
2012-02-22NAINo action indicatedKatena Products, Inc.0
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