MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ACTIVE LIFE PCH STD CLR CUST; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Tissue Damage (2104); Skin Inflammation (2443)

Event Date 02/28/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation (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).

Event Description

Customer reports circumferential red and denuded peristomal skin under the entire mass.She does note a small amount of bleeding from the denuded area when she changes her pouch.She also reports circumferential scatter fluid filled areas under the white tape collar and this area does itch at times.End user stool is loose.End user has been using various products because she has not been able to get the supplies she needs from her current supplier.She cleanses her peristomal skin with moisturizing soap.Instructed on cleansing her peristomal skin with soap that does not contain lotions; moisturizers or creams.She has tried stomahesive paste and barrier rings to her peristomal skin but she is unsure of the manufacturer of the barrier rings.Instructed on crusting with stomahesive powder and protective barrier wipes or water.No wear time established with any of the flat skin barriers she has tried.Date event occurred is an estimate.She has tried security no sting barrier spray to her peristomal skin without success.Recommend a durahesive cut to fit skin barrier without tape collar and convex insert.Instructed if areas worsens or do not improve to call back for additional instructions.

• Brand Name: ACTIVE LIFE PCH STD CLR CUST
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5157263
• MDR Text Key: 28554346
• Report Number: 9618003-2015-30494
• 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: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 67