MegaDerm Ultra® S
MegaDerm Ultra® S
Medical Device
| Principle of action |
This product is an acellular dermal matrix (ADM) that is lyophilized after removing the epidermis, cells and impurities from pig skin, and virus inactivation treatment. It is used to supplement defective or damaged areas of ligaments, tendons, and muscles during internal/surgical treatment and surgery. |
| Purpose of use |
Collagen-containing material used to replenish defective or damaged ligaments, tendons, and muscles during internal/ surgical treatment and surgery |
| Storage method and Shelf life |
1) Room temperature (1~30’C), 2) Avoid direct sunlight and high temperature and high humidity. 3 years from the date of manufacture |
| Precautions for use |
A.Precautions 1) Do not administer to the patient in a manner other than the indicated directions for use. 2) Do not use in patients with weakened immunity or immune disorders. B. General cautions 1) Before using this product, you must read all instructions for use and precautions for use. If the instructions for use and precautions for use are not properly followed, the product may not perform properly or may cause infection or side effects. 2) This product is a product for patient treatment and must be used by medical professionals, and use other than the intended use is prohibited. 3) If side effects are discovered in the transplanted patient, immediately report it to LNCBIO, and the hospital and doctor who performed the transplant take necessary medical measures for the patient. C. Notices regarding adverse events after use of medical device and deadly side effects of 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. D. Precautions regarding age, gender, or health condition for use in consideration of the characteristics of medical devices Due to the nature of the product, if there is an allergic reaction by pigs, it should not be used. Using this product in these patients may cause hypersensitivity reactions such as inflammation, fever, edema, or immune rejection. E. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly It should not be used if the transplant recipient has an allergic reaction to the reagents and solutions used in the preparation of this product before transplantation.It should not be used if there is a possibility that the patient may cause side effects.Particular attention should be paid to immunocompromised patients and patients sensitive to porcine-derived collagen. F. 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. G. Requirements for prevention of accidents 1) It is recommended to use it in an appropriate environment (sterile environment) similar to the manufacturing environment 2) The affected area where the transplantation takes place shall be kept non-contaminated. |
