MAUDE Adverse Event Report: CONVATEC, INC. NATURA DURAHESIVE SKIN BARRIER W/FLANGE; POUCH, COLOSTOMY

Model Number 401901

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Event Description

It was reported after 5 days of use, the end users skin became itchy.The wafer was removed.The skin that was in contact with urine was dark and irritated.The hospital prescribed medicine (name not provided).According to end user, the wafer was darker than usual.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional info becomes available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Based on additional information received on january 27, 2015, one unopened wafer and one opened/unused wafer was received.The opened wafer has edges and center hole cut to fit.The samples received match the description in the record.The investigation is in progress, therefore the final analysis of the evaluation is inconclusive.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 february 5, 2015.

Manufacturer Narrative

The product associated with batch 3g02412 was made according to specification.After detailed batch review, no discrepancies, including non-conformance's/deviations, were found.Return samples were received; however this is a known complaint issue which has been investigated.The returned sample was evaluated to determine that it was indeed convatec product; the associated investigation supports that skin complications may occur with the use of ostomy products.No additional evaluation of the return sample is required.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: february 24, 2016.Fda registration number (b)(4).

• Brand Name: NATURA DURAHESIVE SKIN BARRIER W/FLANGE
• Type of Device: POUCH, COLOSTOMY
• 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: 4346652
• MDR Text Key: 5175735
• Report Number: 1049092-2014-00621
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2018
• Device Model Number: 401901
• Device Lot Number: 3G02412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR