MegaShield®
MegaShield®
Medical Device
| Principle of action |
This product is a dressing, adhesion barrier used to reduce adhesions. It is mainly used after thyroid surgery by injecting it into the surgical site and surrounding tissues. This product contains acellular dermal powder, hyaluronic acid and a thermo-sensitive poloxamer with high biocompatibility. When it reaches body temperature after being applied in the human body, the viscosity becomes higher than at room temperature, forming a physical barrier to reduce adhesion between tissues. For the universal catheter used in this product, a license product (No. 10-1220: universal catheter, 14G-80) is used. A universal catheter is a tube that is combined with the outer tube of the injection container and is used to stably inject the infusate into the surgical site and surrounding tissues. |
| Purpose of use |
1) Dressing, adhesion barrier: Used to reduce adhesion during thyroid surgery 2) Universal catheter: A catheter used to drain a liquid or inject medicine into the body |
| Storage method and Shelf life | Room temperature (1~30 ℃), 2 years from MFD |
| Precautions for use |
A. General precautions 1) Before using the product, be sure to fully understand all the instructions and precautions for use; otherwise, infection and side effect may occur. 2) The product must be utilized only by medical professionals legally allowed to engage in medical practices. Any arbitrary use other than the intended use is prohibited. 3) Since this product is sterile, it should be maintained in a sterile condition during the procedure and should not be used after the expiration date. 4) After inspecting the contents before use, do not use if the packaging and container show signs of damage or moisture. 5) Prior to injecting the product into the surgical site, the surgeon must aspirate any excess fluid, such as lavage fluid, to remove it. 6) If side effects occur in patients who use this product, immediately report it to L&C BIO, and the hospital and doctor who used it will take necessary medical measures for the patient. 7) Store this product at room temperature away from direct sunlight. B. Adverse reactions that may occur as a result of the use of medical devices, Precautions for fatal side effects and accidents caused by negligence in use 1) If any damage or damage to the packaging is found before using the product, it must not be used, and must be returned or exchanged by contacting L&C BIO. 2) If the opened product is left in a contaminated or non-sterile condition before injection into a patient, it should not be used for injection, and it must be returned to L&C BIO or disposed of properly as medical waste. 3) The user’s arbitrary reuse may lead to sterilization destruction and microbial contamination of the product, and if the contaminated product is used, inflammation, fever, edema, allergy may occur. 4) Before using the product, it must be checked whether the patient to be injected has an allergic reaction to the reagents and solutions used in the preparation of the product. 5) If the expiration date of the product has passed, the use of the product is prohibited. If an expired product is used, inflammation, fever, edema may occur. C. Use for pregnant woman, lactating woman, fertile woman, newborn baby, infant, child and senior 1) Before using the product, you must fully understand how to use it and all precautions when using it. If the usage method and precautions are not followed, infection and side effects may occur. 1) There are no clinical data for this product for pregnant women or women of childbearing potential and lactating women who are pregnant or suspected of becoming pregnant. It is not recommended for use for safety reasons. 2) Since clinical trials have not been conducted on the safety and efficacy of this product in newborns, infants, and children, its use is not recommended. D. Application precautions 1) The product should be stored at room temperature before use. 2) The product is gamma-ray sterilized and should not be re-sterilized, and even once opened, the product should not be re-sterilized and reused. 3) Each product is intended for use on only one patient. 4) As it is disposable, the remaining solution much be discarded after use and must not be reused. E. Notices to prevent negligent accident 1) Since this product is manufactured through a GMP process certified by the Ministry of Food and Drug Safety, it is recommended to use this product in an appropriate environment (clean room or operating room) and facility similar to the manufacturing environment. 2) When using the product, be careful not to contaminate the affected area or the treated area. |
