Coloplast SenSura Mio One Piece System Drainable Stoma Bag 10–55mm | 10456 | 10458

Product Overview

SenSura Mio REF 10456 (opaque, neutral grey) and REF 10458 (transparent inspection pouch) are Coloplast's wider one-piece drainable ostomy systems, with the baseplate cuttable from 10 mm to 55 mm. The 55 mm upper limit accommodates patients with larger calibrated stomas, oval or irregular contours, post-surgical oedema (typically the first 6-8 weeks after stoma formation), or peristomal hernia where a wider stable adhesive footprint is clinically preferable. The transparent variant (10458) is selected when stoma viability monitoring is required — for example in the immediate post-operative ward setting or for patients with high-risk vascular pedicles.

The integrated baseplate combines a hydrocolloid skin barrier with Coloplast BodyFit elastic adhesive, designed to follow abdominal movement during respiration, walking, and bending without lifting at the wafer edge. The non-woven textile cover reduces noise and skin friction, while the full-circle pre-filter reduces flatus accumulation and the bag-pancaking phenomenon documented to compromise wear time in active ileostomy patients. Manufactured under Coloplast's ISO 13485 quality management system in Denmark, the appliance is CE marked under EU MDR 2017/745 and FDA 510(k) cleared as a Class II medical device.

Specifications

Clinical Indications

• Adult colostomy and ileostomy patients with stoma diameters or oval lengths exceeding 43 mm
• Immediate post-operative period when stoma swelling extends the effective aperture beyond standard ranges (REF 10458 transparent for viability monitoring)
• Parastomal hernia or significant peristomal scarring where a wider, elastic baseplate footprint is required for stable adhesion
• Patients with high-output ileostomies where the full-circle filter and Easi-Close outlet support frequent draining without baseplate disruption
• Hospital ward, day-surgery, and home-care provisioning where transparent variants are required for nursing assessment
• Active ambulatory patients seeking discreet pouch wear with reduced rustle and ballooning

Frequently Asked Questions

When should the opaque (10456) versus transparent (10458) variant be selected?

The transparent variant (REF 10458) is clinically indicated whenever stoma viability needs direct visual assessment — typically in the first 7-14 days post-operatively, in patients with vascular comorbidity, or when teaching the patient self-care during early adaptation. The opaque grey variant (REF 10456) is preferred for established stoma users seeking discreet daily wear; the neutral colour and non-woven cover render the pouch unobtrusive under fitted clothing.

How does the 10-55 mm aperture differ from the standard 10-43 mm version?How does the 10-55 mm aperture differ from the standard 10-43 mm version?

The wider aperture supports larger calibrated stomas, oval-shaped stomas where the long axis exceeds 43 mm, and post-operative or hernia-affected sites where the adhesive footprint must extend further laterally for stability. Selection should be guided by stoma measurement using the Coloplast measuring guide; the smallest aperture that comfortably accommodates the stoma without compressing it is preferred to maximise peristomal skin protection.

Is the appliance compatible with Coloplast accessories?

Yes. SenSura Mio one-piece systems are compatible with the full Coloplast accessory range, including Brava Protective Seals, Brava Skin Barrier wipes, Brava Adhesive Remover, Brava Elastic Tape (for additional security in active patients), and Brava Lubricating Deodorant Drops. Use of complementary accessories follows ASCN UK and WCET guideline recommendations for individualised peristomal skin care.

What regulatory approvals apply for sale in Singapore?

SenSura Mio is a Class B/C medical device under the HSA risk classification framework, notified through the Singapore Medical Device Register. Coloplast Singapore distributes through authorised channels with full lot traceability, complying with HSA labelling requirements and the Health Products (Medical Devices) Regulations.

How should the pouch be disposed of after use?

Used pouches should be sealed in the supplied disposal bag (where provided) or a sealed plastic bag and disposed of with general household waste in line with Singapore National Environment Agency guidance. Pouches should never be flushed down the toilet — the textile cover, baseplate, and filter are not water-dispersible and will cause plumbing obstruction.