Events

Field Safety Notices about Toothette mouth swab kit with Perox-A-Mint solution, Toothette mouth swab kit with Perox-A-Mint solution and mouth moisturizer, Toothette Perox-A-Mint solution 44 ml, Toothette mouth moisturizer 14 g tube, Q-Care q4 ° kit for mouth cleaning with mint dryer, Toothette Q-Care q4 ° kit for mouth cleaning with mint dryer, Toothette mouth swab dried with Perox-A-Mint solution and mouth moisturizer, Toothette toothbrush with mint dryer and alcohol-free mouth rinse and mouth moisturizer, Q-Care kit for mouth cleaning with mouth dryer small, Toothette Q-Care q8 ° kit for mouth cleansing with coin dryer, Q-Care q4 ° kit for mouth cleansing with coin dryer and Sage Oral Solution Burst Packet, Q-Care q4 ° kit for mouth cleaning with coin dryer and Sage Oral Solution and Q-Care q8 ° kit for mouth cleaning with mint dryer and Sage Oral Solution Burst Packet

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by Sage Products LLC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here

Type of Event
Field Safety Notice
Event ID
6.6.4-2017-64217
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Dentalprodukter--Q-Care-och-Toothette-munvardsprodukter--Sage-Products-LLC/#
Notes / Alerts

Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Sweden.
Extra notes in the data

MDD17.233
Action
Products should be revoked.

Device

Toothette mouth swab kit with Perox-A-Mint solution, Toothette mouth swab kit with Perox-A-Mint s...

Model / Serial
Product Description
Dental products
Manufacturer
Sage Products LLC

Manufacturer

Sage Products LLC

Manufacturer Parent Company (2017)
Stryker
Source
SMPA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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