MAUDE Adverse Event Report: CONVATEC, INC. ACTIVE LIFE PCH URO SM 28MM; BAG, URINARY, ILEOSTOMY

Model Number 175795

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Burning Sensation (2146); Tissue Breakdown (2681)

Event Date 12/18/2013

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer reported that upon removing the pouch, stripped skin around the stoma.Noted superficial redness and burning.Discussed using adhesive remover to remove the pouch.Cleanse with no oil soap.Dust with stomahesive powder and crust with protective barrier wipe.

• Brand Name: ACTIVE LIFE PCH URO SM 28MM
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5138840
• MDR Text Key: 27907038
• Report Number: 1049092-2015-30392
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2016
• Device Model Number: 175795
• Device Lot Number: 1E01183
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91