1368

Organization name

FARMABAN s.a.

SRN

ES-MF-000004713

Manufacturer status

Active

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

• CW083

  EUDAMED did not publish a description for this code.
• CW999

  PRECAUTIONS AND GENERAL CONSIDERATIONS: All Plaster of Paris bandages generate heat during the setting reaction (exothermic reaction) and when applied this heat may be felt by patient. Patients should be instructed to report any pain, numbness, irritation and/or burning sensation. If this occurs, remove the cast or splint immediately. Inspect the cast or splint to determine the cause of the complaints before recasting. Burn injuries may result from improper cast application or failure to observe precautions during and after the setting reaction. Factors that may lead to an excessive exotherm include: Water temperature above 24°C. Overly thick cast or splint. Oversaturation of the plaster. Not changing the dip water frequently. High room temperature. Inadequate air circulation. Use of an additional bandage. Caution must be kept to ensure that the cast or splint is not applied too tightly. Constrictions may result in impaired vascular ow and nerve function. Patients should not put weight on fresh cast or splint. The setting time of YESOLONA Xtra bandages is from 1.6 to 6 minutes and the fully weight-bearing is achieved after 24-48 hours. Factors that may affect the amount of time for the weight-bearing are: humidity, weight of the patient, cast thickness, type of cast and medical professional’s instructions. Advise the patient not to get the cast or splint wet, as Plaster of Paris materials are not resistant to moisture. Advise the patient to take care that no foreign bodies get under the cast, as this may lead to skin irritations. YESOLONA XTRA shall only be used on intact skin. Wound must be covered with a suitable dressing before application of the product. For single use. In case of a serious incident, contact the manufacturer and the responsible health authorities

Primary placement in Spain; available across 6 countries total.

Trade name

not provided

UDI-DI code

08428012113686

Basic UDI-DI

8428012INMOVILIZQX

Reference / catalog number

1368

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

6

Additional product description

Plaster of paris bandage

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 20 MU10
• 2.7 MU36

• M03050202SYNTHETIC CAST BANDAGES AND SPLINTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification