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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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 6
11222019-05: 1 reports for this device2019-07: 1 reports for this device2019-08: 2 reports for this device2019-12: 2 reports for this device05070812
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-051—
2019-071—
2019-082—
2019-122—
This device (reports/month)Average device in its product code (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
2019-12-091037905-2019-00752MalfunctionAvailableexact di
2019-12-061037905-2019-00751MalfunctionAvailableexact di
2019-08-261037905-2019-00497MalfunctionAvailableexact di
2019-08-021037905-2019-00438MalfunctionAvailableexact di
2019-07-251037905-2019-00414MalfunctionAvailableexact di
2019-05-311037905-2019-00300MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-10-24NAINo action indicatedWilson-Cook Medical Inc.0
2014-12-23VAIVoluntary action indicatedWilson-Cook Medical Inc.2
2012-03-06VAIVoluntary action indicatedWilson-Cook Medical Inc.6
2011-06-24WLWarning LetterWilson-Cook Medical Inc.—
2011-04-19OAIOfficial action indicatedWilson-Cook Medical Inc.8
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