MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC SURFIT NATURA PCH DRN SM 38MM; POUCH, COLOSTOMY

Model Number 401506

Device Problem Defective Device (2588)

Patient Problem Skin Irritation (2076)

Event Date 03/03/2014

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation (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

Reporting red, irritated skin inferior to stoma where pouch clip touches skin.Area increased in size and outward away from pouch area toward middle of abdomen.End user is keeping pouch clip away from skin and area has since decreased in size.

• Brand Name: SURFIT NATURA PCH DRN SM 38MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155840
• MDR Text Key: 28463301
• Report Number: 9618003-2015-30467
• 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: Patient
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 401506
• Device Lot Number: 3J02674
• 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: 10/01/2013
• 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 Weight: 63