U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The labeling for the iamin family of medical devices (e.G. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.
조치
PhotoMedex sent an Urgent product Recall notification, dated March 2015, to direct consignees requesting they discontinue use, complete the response form, and return affected products.
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.