MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE PCH DRN CVX 25MM; POUCH, COLOSTOMY

Model Number 125354

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer developed a dime size ulcer in previous reported complaint.He then switched to wearing the active life pch drn cvx 25mm and the ulcer has since increased in size to about the size of a quarter.He is treating with sh powder.Declined offer to send flat wafers and eakins to remove the pressure from the convexity.Suggested he see an ostomy nurse if the area does not improve.Explained how the ulcer could be from the pressure of the convexity and the pressure should be eliminated in order for the area to heal.

• Brand Name: ACTIVE LIFE PCH DRN CVX 25MM
• Type of Device: POUCH, COLOSTOMY
• 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: 5154039
• MDR Text Key: 28436340
• Report Number: 1049092-2015-30580
• Device Sequence Number: 1
• Product Code: EZQ
• 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: Patient
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/12/2019
• Device Model Number: 125354
• Device Lot Number: 4E01310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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