| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01234-1 |
| Product Name/Description |
miraDry System (used for the treatment of primary axillary hyperhidrosis)
All batches affected
ARTG Number: 223967 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
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.” |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
03 9998 2020 - Device Technologies |