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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.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-06-06OAIOfficial action indicatedPreservation Solutions, Inc.3
2025-06-06OAIOfficial action indicatedPreservation Solutions, Inc.3
2023-07-14OAIOfficial action indicatedPreservation Solutions, Inc.3
2023-07-14OAIOfficial action indicatedPreservation Solutions, Inc.3
2021-09-30OAIOfficial action indicatedPreservation Solutions, Inc.9
2021-09-30OAIOfficial action indicatedPreservation Solutions, Inc.9
2019-03-12OAIOfficial action indicatedPreservation Solutions, Inc.7
2019-03-12OAIOfficial action indicatedPreservation Solutions, Inc.7
2018-08-10VAIVoluntary action indicatedPreservation Solutions, Inc.7
2018-08-10VAIVoluntary action indicatedPreservation Solutions, Inc.7
2017-08-21WLWarning LetterPreservation Solutions, Inc.—
2017-08-21WLWarning LetterPreservation Solutions, Inc.—
2017-05-19OAIOfficial action indicatedPreservation Solutions, Inc.13
2017-05-19OAIOfficial action indicatedPreservation Solutions, Inc.13
2015-08-31VAIVoluntary action indicatedPreservation Solutions, Inc.8
2015-08-31VAIVoluntary action indicatedPreservation Solutions, Inc.8
2011-09-30NAINo action indicatedPreservation Solutions, Inc.0
2011-09-30NAINo action indicatedPreservation Solutions, Inc.0
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