MAUDE Adverse Event Report: CONVATEC, INC. NATURA DURA FLATMLD L 57MM; PROTECTOR, OSTOMY

Model Number 411804

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 11/25/2013

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).(b)(4).

Event Description

Customer reports redness to her peristomal skin from approximately 500-700 o'clock with a small amount of bleeding noted when she cleanses her peristomal skin.This redness extends outward approximately 7mm.She does experience some pain from this area.She changes her wafer every 4 days.She sees a little bit of skin exposed when she applies her large moldable skin barrier.She applies eakin cohesive slim to her peristomal skin.She uses stoma powder to her peristomal skin to her peristomal skin.She uses adhesive releaser to her peristomal skin.She uses peristomal wipes and no sting protective barrier wipes to her peristomal skin.Instructed on crusting with stoma powder and protective barrier wipes or water.She also reports circumferential scattered red rash like area under the hydrocolloid tape collar.She does experience itching from both red area and the red rash like area.Recommend medium moldable skin barrier with acrylic collar.

• Brand Name: NATURA DURA FLATMLD L 57MM
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5145912
• MDR Text Key: 28104908
• Report Number: 1049092-2015-30419
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 411804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2014
• 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 Weight: 67