MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM® + CONVEX ONE-PIECE DRAINABLE PRE-CUT; POUCH, COLOSTOMY

Model Number 416738

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

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(6).(b)(4).

Event Description

It was reported the skin barrier is difficult to remove from the end user's skin after five days of wear and the use of adhesive remover.As a result, the end user has experienced minimal bleeding and skin tears under the skin barrier.The end user was encouraged to attempt to remove the product while in the shower.No further patient complications were reported.

Manufacturer Narrative

This supplemental report is being submitted as no lot number is available and a detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process no additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on june 12, 2017.Fda registration number: reporting site: (b)(4).Manufacturing site: (b)(4).

• Brand Name: ESTEEM® + CONVEX ONE-PIECE DRAINABLE PRE-CUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; director, quality complaint; handling unit, 7900 triad ctr; dr., ste 400 greensboro,, NC 27409 ; 3365424681
• MDR Report Key: 5153131
• MDR Text Key: 28388807
• Report Number: 1049092-2015-00613
• 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
• Type of Report: Followup
• Report Date: 09/30/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• 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: Initial
• Patient Sequence Number: 1
• Treatment: XANAX
• Patient Weight: 82