Proluma

Trade name

Proluma

08800125100744

B-08800125100744

Reference / catalog number

Not applicable

GS1

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Sterile Absorbable Poly-L-Lactic acid(PLLA) Dermal Filler

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 365 MU37

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040203DERMAL REGENERATION EQUIPMENT

2 warnings recorded — scroll inside the panel to see all entries.

• Warnings 1. The product should be injected only into the lower layers of the dermis or the layers of the hypodermis. 2. Like other injections, in cases of the patients who have been administered anticoagulants, the product may carry the risk of haematoma or local bleeding in the injection site. 3. Do not inject the product at a shallow depth, closer to the outer layer of the skin, in order to prevent early papules or nodules at the injection site. 4. If the product is injected into blood vessels, it may obstruct the blood vessels or their flow, and cause skin embolism. 5. In order to avoid contamination, each vial package must be used for one single patient only. Since the product is a disposable single-use material, do not re-use or re-sterilize after opening its seal or reconstituting the solution. 6. If the sealed package is broken, damaged or modified, do not use the product. 7. It is strictly prohibited to use the product for other purposes except its originally intended purpose. 8. Before treatment, make sure that the prepared product has completed the reconstitution as it is indicated in the preparation guideline of the product. 9. A sterile, disposable 26G needle or cannula must be used for this injection treatment.

  OTHER

• Contraindications 1. Do not inject the product into patients with acute or chronic skin diseases (infection or inflammation) either at the injection site or surrounding areas. 2. Do not inject the product into patients who are highly sensitive to the product and its components. 3. The safety of using the product on patients with susceptibility to excessive scarring (keloids) has not been established. 4. If the product is injected into patients who have a history of herpetic eruption, then herpetiformis may recur. 5. Do not inject the product into patients with malfunction of the liver or blood coagulation.

  OTHER