Application/Indication

Cosmopor E steril is a non-active, non-invasive, single-use, sterile self-adhesive dressing consisting of an adhesive coated backing material (carrier material) and a woundpad, protected with a silicone paper, for the protection of postsurgical / primary wounds and absorption of exudate (wounds with a normal exudate production).
The product is intended for humans, without restrictions (in age group, weight range, health status or condition), for use by healthcare professionals and lay-users, in contact with intact skin (healthy skin) and breached skin, and short term (60 minutes ≤ Duration ≤ 30 days, acc. to MDR) / prolonged use (24 hours < Duration ≤ 30 days, acc. to ISO 10993-1:2018) duration of use.

Contraindications

Not indicated to be applied on non-treated infected wounds, ulcers or chronic wounds.

Sterile Device

Prevention symbols added

Single Use Device

Reusing a single-use medical device is dangerous. Reprocessing devices, in order to reuse them, may seriously damage their integrity and their performance. Information available on request.

Product Disposal

To minimize the risk of potential infection hazards, or environmental pollution, disposable components of Cosmopor E steril should follow disposal procedures according to applicable and local laws, rules, regulations and infection prevention standards.

Incident Reporting

For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorised representative and to your national authority.