MAUDE Adverse Event Report: CONVATEC, INC ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE; POUCH, COLOSTOMY, 78EZQ

Model Number 125353

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

Patient Problems Rash (2033); Increased Sensitivity (2065); Fungal Infection (2419)

Event Date 07/21/2014

Event Type  Injury  

Event Description

It is reported that end-user developed a fungal rash to the left lower quadrant (llq) of peristomal skin associated with the product which is located 360 degrees around the adhesive border of the wafer, but does not extend under the mass or the adhesive border.It was further reported that treatment was provided with antifungal ointment ketoconazole, as prescribed by her physician which was only used a few times due to its moisture, the appliance failed to adhere/bond to skin.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.End-users husband was provided instructions in skin care to include crusting techniques using an antifungal powder and a no sting protective barrier wipe.Lastly, end-user was instructed to notify convatec with any questions or concerns, and end-user will be sent samples of the sensi-care product and a more flexible system product number 416724 (esteem drainable pouch, 25mm 1 in, cl, st, filter, invisi, 10,).No additional pt/event details have been provided to date.A return sample for eval is not expected.Should additional info become available, a follow-up report will be submitted.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

Manufacturer Narrative

(b)(4).The product associated with batch 4c00022 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.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 1 PC DRAINABLE POUCH W/DURAHESIVE
• Type of Device: POUCH, COLOSTOMY, 78EZQ
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4024565
• MDR Text Key: 16085937
• Report Number: 1049092-2014-00389
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2019
• Device Model Number: 125353
• Device Catalogue Number: 125353
• Device Lot Number: 4C00022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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 Outcome(s): Required Intervention