Events

Recall of miraDry System (used for the treatment of primary axillary hyperhidrosis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Consulting Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01234-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01234-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Device consulting has been advised that clinics may use substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly containing and cooling the skin and cause minor burns and blisters. whilst there have not been any adverse events reported in australia, device consulting is updating the user manual for the miradry system to include the statement: “do not use lubricants other than the recommended lubricants (k-y jelly or k-y liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
  • Action
    Device Consulting is providing users with an updated user manual, including additional warnings regarding the use of non-validated solutions. This action has been closed-out on 26/08/2016.

Device

miraDry System (used for the treatment of primary axillary hyperhidrosis)
  • Model / Serial
    miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967
  • Manufacturer
    Device Consulting Pty Ltd

Manufacturer

Device Consulting Pty Ltd