MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM PCH CVXDRNWFINVISITAN 25MM; POUCH, COLOSTOMY

Model Number 416743

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

Patient Problem Tissue Damage (2104)

Event Date 02/26/2014

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 reports redness and bleeding noted when she changes her pouch at the mucocutaneous juncture line.No bleeding noted at this time.She uses water to cleanse her peristomal skin.She applies eakin cohesive seal to her peristomal skin.She uses sensicare adhesive remover and protective barrier to her peristomal skin.She applies stomahesive powder to her peristomal skin.She changes her pouch every 5 days.Instructed on crusting with stomahesive powder and protective barrier or water.Instructed if area worsens or does not improve to call back for additional instructions.

• Brand Name: ESTEEM PCH CVXDRNWFINVISITAN 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: 5153072
• MDR Text Key: 28382795
• Report Number: 1049092-2015-30457
• 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: Lay User/Patient
• Device Expiration Date: 09/18/2018
• Device Model Number: 416743
• Device Lot Number: 3J00640
• 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
• Date Device Manufactured: 09/19/2013
• 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: 51