Skip to content
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.

7 linked reportsInjury 7
24572019-09: 7 reports for this device; peer average 7/device09
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0977
This device (reports/month)Average device in MMO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2019-09-203011270181-2019-00034InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00033InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00037InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00036InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00035InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00038InjuryAvailableprocode brand trgm
2019-09-203011270181-2019-00032InjuryAvailableprocode brand trgm
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-12-15VAIVoluntary action indicatedAvanos Medical, Inc.3
2023-12-15VAIVoluntary action indicatedAvanos Medical, Inc.3
2018-10-02VAIVoluntary action indicatedAvanos Medical, Inc.1
2018-10-02VAIVoluntary action indicatedAvanos Medical, Inc.1
2016-07-29VAIVoluntary action indicatedAvanos Medical, Inc.1
2016-07-29VAIVoluntary action indicatedAvanos Medical, Inc.1
2014-11-05NAINo action indicatedAvanos Medical, Inc.0
2014-11-05NAINo action indicatedAvanos Medical, Inc.0
2014-03-07VAIVoluntary action indicatedAvanos Medical, Inc.4
2014-03-07VAIVoluntary action indicatedAvanos Medical, Inc.4
2013-12-10NAINo action indicatedAvanos Medical, Inc.0
2013-12-10NAINo action indicatedAvanos Medical, Inc.0
2013-04-10WLWarning LetterAvanos Medical, Inc.—
2013-04-10WLWarning LetterAvanos Medical, Inc.—
2013-01-04OAIOfficial action indicatedAvanos Medical, Inc.6
2013-01-04OAIOfficial action indicatedAvanos Medical, Inc.6
2012-10-31OAIOfficial action indicatedAvanos Medical, Inc.10
2012-10-31OAIOfficial action indicatedAvanos Medical, Inc.10
2011-07-08VAIVoluntary action indicatedAvanos Medical, Inc.8
2011-07-08VAIVoluntary action indicatedAvanos Medical, Inc.8
2010-11-19OAIOfficial action indicatedAvanos Medical, Inc.4
2010-11-19OAIOfficial action indicatedAvanos Medical, Inc.4
2008-12-22WLWarning LetterAvanos Medical, Inc.—
2008-12-22WLWarning LetterAvanos Medical, Inc.—
Similar devices
Select up to two to place side-by-side with this device.