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

Model Number 175783

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

Patient Problems Skin Irritation (2076); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

An end user reported that she was diagnosed with a fungal infection to her peristomal skin while using the active life convex one-piece pouch.Her physician prescribed nyamyc powder for treatment which she has been applying daily to the affected area.

Manufacturer Narrative

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.(b)(4).

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5510471
• MDR Text Key: 40672083
• Report Number: 1049092-2016-00097
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2020
• Device Model Number: 175783
• Device Lot Number: 5K03204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• 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: 68 YR
• Patient Weight: 86