Events

Safety Alert for ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by ConMed.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-05-20
  • Event Date Posted
    2016-05-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160520.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: conmed thermoguard plus abc paediatric dual dispersive electrodes the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning thermoguard plus abc paediatric dual dispersive electrodes [reference number: 7-383; lot codes: 141010x to 20150705x], manufactured by conmed. the thermogard dual dispersive electrode pads are not compatible with some brands of electrosurgical generators using “passive” cqm (contact quality monitoring) systems. whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a “passive” cqm electrosurgical generator. the manufacturer is advising users to inspect stock and discontinue use of affected devices. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00653-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2016.

Device

ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
  • Manufacturer
    ConMed

Manufacturer

ConMed