Safety alert issued by the Federal Office for Safety in Health Care regarding Dermapen 3 Microneedles.
The Federal Office for Safety in Health Care (BASG) has prohibited the further placing on the market by decision of 06.04.2020 and warns against the further use of the following product:
- "Dermapen 3 Microneedles" of the manufacturer "Equipmed USA".
The products of the manufacturer Equipmed USA are also marketed under the name of the companies DermapenWorld and Equipmed USA LLC.
The micro-needling devices called Dermapen are used for the treatment of scars, wrinkles and pigmentation disorders, among others. The Dermapen 3 product is used in combination with corresponding needle attachments (Dermapen 3 Microneedles).
In the course of a preliminary investigation, the BASG determined that the above-mentioned product was unlawfully placed on the market. The CE marking located on the product was affixed without a corresponding conformity assessment having been carried out. With this letter, the BASG points out that the product in question is thus a medical device that is not marketable.
The safety of this medical device has not been proven. Based on the information currently available, the Federal Office therefore warns all potential users against further use of this medical device.
Patients affected are advised to contact their attending physician if necessary.
Furthermore, we would like to remind you of the obligation to report. According to § 70 MPG, any incident that could lead to a serious health impairment or death of a patient, user or third party must be reported immediately to the Federal Office for Safety in Health Care. The reporting forms can be found online at www.basg.gv.at/medizinprodukte/formulare/mp-zwischenfall/.
|Medical devices||Dermapen 3 Microneedles|
|Distributor||DermapenWorld und Equipmed USA LLC|