MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC ESTEEM PCH CLD WF STDTAN 60/70MM; POUCH, COLOSTOMY

Model Number 416701

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 convatec remediation protocol (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 circumferential redness which extends outward approximately 13mm and she does note a small amount of bleeding when she changes her pouch.No bleeding noted at this time.Redness is still present.She uses adhesive remover to her peristomal skin.She uses ivory soap to cleanse her peristomal skin.She uses protective barrier wipes to her peristomal skin.Instructed on crusting with stomahesive powder and protective barrier wipes.End user stoma measures 45mm but she has been cutting the opening to 50mm.Instructed on how to properly measure and cut the opening for her stoma.End user has a peristomal hernia.

• Brand Name: ESTEEM PCH CLD WF STDTAN 60/70MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC; carr. sanchez, km. 18.5; parque industrial, haina; san cristobal, 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155722
• MDR Text Key: 28458193
• Report Number: 9618003-2015-30643
• 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: No Information
• Device Expiration Date: 02/06/2019
• Device Model Number: 416701
• Device Lot Number: 4A04042
• 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: 02/07/2014
• 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 Weight: 61