MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE® CONVEX ONE-PIECE PRE-CUT POUCH; POUCH, COLOSTOMY

Model Number 175783

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

Patient Problems Itching Sensation (1943); Tissue Damage (2104); Burning Sensation (2146); Skin Inflammation (2443); Fluid Discharge (2686)

Event Type  Injury  

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.Reported to the fda on april 13, 2016, (b)(4).

Event Description

It was initially reported by the end user on (b)(6) 2016 that she exhibited a red bumpy rash under the left side and bottom part of tape collar that included itching and burning.Additional information received on (b)(6) 2016 from the end user stated that the peristomal skin issue is persisting with red, open, weepy and itchy skin under the tape collar portion.She has prescribed nystatin powder by a physician, however little improvement with the nystatin powder has been noted.She saw a dermatologist who diagnosed the skin issue as contact dermatitis.

• Brand Name: ACTIVELIFE® CONVEX ONE-PIECE PRE-CUT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5575068
• MDR Text Key: 42605865
• Report Number: 1049092-2016-00154
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• 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
• Treatment: DESENEX POWDER, SUREPREP SPRAY, BRAVA STRIP
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR