Description
Medical device useful for improving the joint mobility of the shoulder and upper limb, whose primary therapeutic treatment consists of the following functions:
1. Barrier effect.
2. Lubricating activity.
3. Mechanical support in case of ongoing pharmacological therapy.
The use of MD-SHOULDER by qualified healthcare personnel, in private or public healthcare facilities, is recommended for:
- improving the mobility of the shoulder joint and upper limb;
- promoting muscle relaxation;
- supporting muscle structures;
- relieving localized pain and pain caused by movement.

Directions for use
MD-SHOULDER can be used alone or in combination with other medical devices belonging to the same line, in order to ensure a personalized treatment based on the individual clinical picture.
In cases where supportive treatment is required for acute pain, MD-SHOULDER can be combined with MD-NEURAL, MD-POLY, and MD-MUSCLE (one or more of these).
Furthermore, in cases where supportive therapy for tissue matrix is required or an action to slow down physiological aging is necessary, MD-SHOULDER can be combined with MD-MATRIX and MD-TISSUE.

Therapeutic protocol:
1-2 treatments per week for 10 consecutive weeks.

Perarticular injectable administration method (the application area must be aseptic; insert the needle near the joint to a depth of 2-4 mm).
For this use of the medical device, the following materials and accessories are recommended:
• Material to ensure skin asepsis: disposable gloves, iodine-based solution, alcoholic solution, sterile gauze, ethyl chloride-based skin spray.
• Needles: sterile 27 G.
• Syringes: 5 or 10 cc, depending on the quantity of solution to be injected.

Intra-articular injectable administration method.
For this use of the medical device, the following materials and accessories are recommended:
• Material to ensure skin asepsis: disposable gloves, iodine-based solution, alcoholic solution, sterile gauze, ethyl chloride-based skin spray. It is recommended to apply local anesthetic to the treated skin.
• Needles: sterile 22 G.
• Syringes: 5 or 10 cc, depending on the quantity of solution to be injected.

- Intra-articular injection treatment of the shoulder, anterior part: The patient's hand rests on the thigh, while the shoulder muscles are relaxed. The glenohumeral joint can be palpated with the fingers between the coracoid process and the head of the humerus. As the shoulder is rotated inwards, the head of the humerus can be palpated by rotating inwards and the joint space felt as a depression located laterally to the coracoid process. Insert a 22 G needle laterally to the coracoid process. Direct the needle into the joint space.

- Intra-articular injection treatment of the shoulder, posterior part: The posterior part of the shoulder joint can be identified by rotating the patient's arm. This position can be achieved by resting the patient's ipsilateral hand on the contralateral shoulder. The head of the humerus can be palpated by placing a finger posteriorly on the acromion, while the shoulder is rotated. Insert a 22 G needle approximately 1 cm inferior to the posterior tip of the acromion and direct it anteriorly and medially.

Components
Collagen of porcine origin.
Excipients: Iris, NaCl, injectable water.

Warnings
Single use.
No cases of hypersensitivity to MD-SHOULDER have been reported.
Contains collagen of animal origin from swine species.
Patients with confirmed hypersensitivity to the component or excipients must first undergo an injection test in the arm and be kept under observation for one hour.
Shoulder pain requires differential diagnosis with chronic cervical syndrome, ischemic heart disease (acute/chronic, for left shoulder only), cholecystitis/cholelithiasis (for right shoulder only), cervicobrachialgia, trapezius muscle trigger point.
Slight redness in the injection area may be due to the mechanical effect of the needle or a skin reaction.
The application may cause burning/pain symptoms at the injection sites, which usually resolve within 5-10 minutes after the end of treatment.
Skin cleaning/disinfection is required before and after application.
Any pyogenic bacteria could produce an abscess in the injection area.
Keep out of reach and sight of children.
Do not use after the expiry date.
Use the product immediately after opening.
Do not use if the seal is broken or tampered with.
After opening, the contents of the vial must be injected immediately.
Do not use if the packaging is damaged.

Storage
Store at a temperature between 2°C and 30°C, protect from sunlight and frost.
The expiry date refers to the product in intact packaging, correctly stored.

Format
Pack of 10 sterile 2 ml vials

Code MD10