MAUDE Adverse Event Report: CONVATEC LIMITED S4S/SUR-FIT NATURA 2PC-2PC DRAINABLE POUCH-INVISICLOSE POUCH W/FILTER; POUCH, COLOSTOMY

Model Number 411361

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a red rash like area under her pouch, to her right thigh and groin area.The end user does experience itching rom these areas.The end user changes her pouch every 3-4 days.The end user subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: S4S/SUR-FIT NATURA 2PC-2PC DRAINABLE POUCH-INVISICLOSE POUCH W/FILTER
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, director, post ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4109745
• MDR Text Key: 4757824
• Report Number: 1000317571-2014-11456
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2017
• Device Model Number: 411361
• Device Lot Number: 2J00586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 94