MAUDE Adverse Event Report: CONVATEC INC. NATURA DURA FLATMLD 45/70MM; PROTECTOR, OSTOMY

Model Number 411806

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Skin Irritation (2076); Tissue Damage (2104)

Event Date 08/01/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

It was reported by the wife of the patient that stool has been leaking under the skin barrier persistently resulting in the need for frequent changes.His skin is red and irritated and now he has 3 small open areas 0.5 cm diameter or smaller.The stoma is flush to retracted.She has applied sh powder.She was using a generic adhesive remover before applying the appliance.She does not know what brand but it was oily and she was not washing it off.Discussed use of accessories; alt options for pouching.

• Brand Name: NATURA DURA FLATMLD 45/70MM
• 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: 5155118
• MDR Text Key: 28449166
• Report Number: 1049092-2015-30588
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 07/01/2019
• Device Model Number: 411806
• Device Lot Number: 4F02007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• 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