AQUACEL

Main information

  • Trade name:
  • AQUACEL Ag Hydrofiber Dressing with Silver & Strengthening Fibre - Dressing, hydrophilic gel-forming
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AQUACEL Ag Hydrofiber Dressing with Silver & Strengthening Fibre - Dressing, hydrophilic gel-forming
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216812
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216812

Convatec Australia Pty Ltd - AQUACEL Ag Hydrofiber Dressing with Silver & Strengthening Fibre -

Dressing, hydrophilic gel-forming

ARTG entry for

Medical Device Included Class III

Sponsor

ConvaTec Australia Pty Ltd

Postal Address

PO Box 63,MULGRAVE, VIC, 3170

Australia

ARTG Start Date

1/11/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Convatec Limited

Unit 20 1st Avenue Deeside Industrial Park

Deeside, Flintshire, CH5 2NU

Products

1. AQUACEL Ag Hydrofiber Dressing with Silver & Strengthening Fibre - Dressing, hydrophilic gel-forming

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

43186 Exudate-absorbent dressing, hydrophilic-gel

Functional description

AQUACEL Ag absorbs & retains exudate by hydrophilic action. The dry dressing hydrates on contact with

wound fluid. The fibers swell while absorb exudate & bacteria, forming a soft, cohesive, clear gel. The

silver kills a broad spectrum of wound bacteria, aiding to create an antimicrobial environment.

Antimicrobial activity reduces return of viable bacteria back into the wound.

The moist environment & control of wound bacteria support the body's healing & helps reduce risk of

wound infection.

Intended purpose

AQUACEL Ag Hydrofiber with Silver & Strengthening Fibre is intended to be used where a ribbon

presentation is considered most appropiate, for the management of:

- Wounds where there is an infection or an increased risk of infection;

- Partial thickness (second degree) burns;

- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology)

and pressure ulcers/sores (partial & full thickness);

- Surgical wounds;

- Traumatic wounds;

- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided;

- Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous

metastasis, Kaposi's sarcoma, and angiosarcoma.

Variant information

Size (cm) 1cm x 45cm

Size (cm) 2cm x 45cm

Size (cm) 2.5cm x 40cm

Size (cm) 2.5cm x 45cm

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:11:27 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information