MAUDE Adverse Event Report: CONVATEC INC. ESTEEM CVX DRN STD TAN 25MM; POUCH, COLOSTOMY

Model Number 411602

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 06/14/2013

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).(b)(4).

Event Description

It was reported that adhesive is too aggressive, leaves reddened skin.

• Brand Name: ESTEEM CVX DRN STD TAN 25MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5290131
• MDR Text Key: 33300529
• Report Number: 1049092-2015-40106
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/30/2017
• Device Model Number: 411602
• Device Lot Number: 2K03242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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