MegaDerm® Plus
MegaDerm® Plus
Medical Device
| Principle of action |
MegaDerm® Plus is Acellular Dermal Matrix (ADM) that has removed the epidermis and cells from the human skin and is cross-linked using a cross-linking agent. It is a product of freeze-dried square Sheet type, Powder type, and rod-shaped Carving type with rounded ends. |
| Purpose of use | It is used for replacement or restoration of human skin that has been depressed or damaged by an accident or disease. |
| Storage method and Shelf life | Room temperature (1~30℃), 3 years from the date of manufacture |
| Precautions for use |
A. General notices 1) The instruction for use and precautions shall be read and unless the user follow the instruction for use and precautions, performance, infection, or side effects may arise. 2) It shall be used only by medical professionals and be used only as intended. 3) If side effects are discovered in the transplanted patient, immediately report it to the Ministry of Food and Drug Safety, and the hospital and doctor who performed the transplant will take necessary medical measures for the patient. B. Notices regarding adverse events after use of medical device, deadly side effects or accidents due to careless handling 1) If any breakage or damage to the packaging is found before using the product, it must not be used for transplantation, and must be returned or exchanged by contacting L&C BIO. 2) If an opened product is left in a contaminated or non-sterile state before transplantation into a patient, it must not be used for transplantation. 3) Before use for transplantation, it must be checked whether the recipient has an allergic reaction to the reagents and solutions used in the manufacture of this product. 4) This product must be used within the expiry date of the product, and if the product has expired, you must contact L&C BIO for a return or exchange. 5) Store this product in a cool, dry place, avoiding direct sunlight, according to the recommended storage conditions. 6) Before transplantation, if the recipient has an allergic reaction to the reagents and solutions used in the manufacture of this product, it should not be used. It should not be used if the patient has the potential to cause adverse reactions. Special attention should be paid to immunocompromised patients. C. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly 1) There are no clinical data for this product for pregnant women or women of childbearing potential and lactating women. Therefore, its use is not recommended for safety reasons. 2) Since clinical trials have not been conducted on the safety and efficacy of this product for newborns, infants, children and the elderly, its use is not recommended. D. Notices in application Describe the necessary precautions according to the instructions for use, etc. 1) This product is an e-beam (electron beam) sterilized product and must not be re-sterilized, and once opened, the product must not be re-sterilized and reused. 2) This product is rehydrated and used in a fully hydrated state before use. 3) Each individually packaged product should only be used on one patient. E. Requirements for prevention of accidents 1) MegaDerm PLUS is processed at clean facility and factory certified from MFDS (Former KFDA) and shall be used at aseptic environment. 2) The affected area where the transplantation takes place shall be kept non-contaminated. |
