Bulkamid® Hydrogel

Organization name

Contura International A/S

SRN

DK-MF-000002018

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

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

  Bulkamid® Urethral Bulking System is contraindicated in: • Patients suffering from acute cystitis or urethritis. • Patients who have active Herpes Genitalis. • Patients with damaged tissue in the urethra.
• CW999

  WARNINGS • Do not inject Bulkamid® Hydrogel intravascularly. It is possible that accidental vascular injection will cause embolism. • During the bulking procedure, the blood vessels must always remain visible at the site of injection to avoid the risk of necrosis. • Evaluate the condition of the tissue (e.g. hardness, oedema, haematoma, atrophy) at the site of injection prior to treatment. • Patients receiving treatment interfering with blood coagulation have an increased risk of haematoma or urethral bleeding.

Primary placement in Netherlands; available across 25 countries total.

Trade name

Bulkamid® Hydrogel

UDI-DI code

05704101500098

Basic UDI-DI

5704101BulkamidCG

Reference / catalog number

50009

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Bulkamid® Hydrogel is a non-absorbable, injectable transparent, hydrophilic gel for urethral bulking. Bulkamid® Hydrogel consists of 2.5% cross-linked polyacrylamide and 97.5% non-pyrogenic water. It is biocompatible and non- biodegradable. Bulkamid® Hydrogel is supplied in a pre-filled, sterile, 1 mL syringe, sealed with a Tip Cap in a Luer lock fitting.

Additional information URL

https://contura.com/urinaryincontinence/

Clinical sizes

• 1 MU48

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

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

• U070199INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER

Certificate health across this manufacturer's portfolio.