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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
  • 510(k)K103744Substantially equivalent (SESE) · 2011-05-12clearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-01-30NAINo action indicatedPolymer Technology Systems, Inc.0
2023-01-30NAINo action indicatedPolymer Technology Systems, Inc.0
2021-09-07VAIVoluntary action indicatedPolymer Technology Systems, Inc.2
2021-09-07VAIVoluntary action indicatedPolymer Technology Systems, Inc.2
2019-07-31WLWarning LetterPolymer Technology Systems, Inc.—
2019-07-31WLWarning LetterPolymer Technology Systems, Inc.—
2019-02-15OAIOfficial action indicatedPolymer Technology Systems, Inc.7
2019-02-15OAIOfficial action indicatedPolymer Technology Systems, Inc.7
2017-06-21NAINo action indicatedPolymer Technology Systems, Inc.0
2014-08-07NAINo action indicatedPolymer Technology Systems, Inc.0
2014-08-07NAINo action indicatedPolymer Technology Systems, Inc.0
2013-11-01NAINo action indicatedPolymer Technology Systems, Inc.0
2012-07-20VAIVoluntary action indicatedPolymer Technology Systems, Inc.2
2012-07-20VAIVoluntary action indicatedPolymer Technology Systems, Inc.2
2010-02-25NAINo action indicatedPolymer Technology Systems, Inc.0
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