MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVE LIFE PCH STD CLR CUST (1X10PK) US; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Skin Discoloration (2074); Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

The end user reports redness under the left side of the white tape collar which extends outward approximately 25mm.She said the location of this redness under the white tape varies but is on the left at this time.She also reports circumferential redness to her peristomal skin directly next to her stoma where it is not covered by the mass which measures approximately 5mm.She said she cuts the opening for her stoma approximately 25mm larger than her stoma because she has experienced pain in the past when the stool would pass when the opening was so close to her stoma.The end user was prescribed hydrocortisone 2.5% to the reddened area beyond the white tape collar, as well as nystatin cream to be applied to the peristomal skin directly next to her stoma by her physician.No further details have been provided.

• Brand Name: ACTIVE LIFE PCH STD CLR CUST (1X10PK) US
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5901135
• MDR Text Key: 52955415
• Report Number: 9618003-2016-00041
• 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
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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: 08/04/2016
• 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 Age: 74 YR
• Patient Weight: 43