MAUDE Adverse Event Report: COLOPLAST SENSURA XPRO CONVEX 1 PC DRAINABLE OSTOMY POUCH

Model Number 15695

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Anxiety (2328); Depression (2361)

Event Date 01/01/2010

Event Type  Injury  

Event Description

Ongoing issues with product defects resulting in repeated fecal failures from the coloplast sensura xpro convex ostomy pouch.This has been a 7 year battle with product quality decidedly degraded since 2013.I have photos of issues which go beyond application and fit.The product sadly is the best fit of these in the marketplace i have found since my last surgery in 2007.The issues cost me a career and exacerbated my depression along with developing panic and anxiety attacks.My 2013 the failures were so bad i was advised by a medical professional to file for disability because of all the jobs i had lost due to feces draining on me at any given time.In front of clients, during job interviews, in my car on the expressway, in my bed, ss approved my claim immediately, but even then i lost everything, my career, my vehicle, my home and furnishings.I still have no credit score.From the corporate double speak they are hiding the fact of poor quality in mfg.They have changed over the cheaper materials.Now that so many people have expanded into medicaid, they can sell more products and make it cheaper.They have also increased product offerings to offset the lower quality of the pouches.Lifting at the edge of the barrier became a problem in the past 2 years and rather than use a quality adhesive material that worked in the past.They now sell an extra product to correct the lift.Medicare and medicaid get billed (b)(6) per month.I get because of the human body failures can happen.I have dealt with way above the average because of poorly made stoma by the surgeon.That is bad enough, but my logs and photos show the decline in product quality with the expansion of insurance coverage.I truly think there is a deliberate coverup and fraud.The more failures the more people need to apply a new pouch, so the more they need to buy.I did consult a stoma clinic and they told me i was skilled with applying the pouch and using the skin barrier patches i hand trimmed to give me the optimum protection.Meaning i knew what i was doing and was using the best mix for my body.

• Brand Name: SENSURA XPRO CONVEX 1 PC DRAINABLE OSTOMY POUCH
• Type of Device: OSTOMY POUCH
• Manufacturer (Section D): COLOPLAST
• MDR Report Key: 7049085
• MDR Text Key: 92765344
• Report Number: MW5073468
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 15695
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 64