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 Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer reports red and denuded peristomal skin from 300-1200 o'clock which extends outward approximately 38mm.She does experience a small amount of bleeding from this area when she changes her pouch.No wear time established.Her stoma is stenosed and it is dilated by her doctor regularly.She has an umbilical hernia.She uses stomahesive paste to her peristomal skin.She uses stomahesive powder followed by protective barrier wipes.She uses an adhesive remover to her peristomal skin but she is unsure of the brand and does not have any more left.She has had this red and denuded for months but she is unsure of when it started.She has lost (b)(6) lbs over the past year.Instructed to cleanse peristomal skin with soap that does not contain lotions; moisturizers or creams.

• 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: 5156397
• MDR Text Key: 28515961
• Report Number: 9618003-2015-30474
• 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: 88