MAUDE Adverse Event Report: CONVATEC LIMITED S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 411491

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

Patient Problems Skin Discoloration (2074); Skin Tears (2516)

Event Type  Injury  

Event Description

Per the end user, there is a red rash with areas of broken skin under the pouch.Pouch is changed every 2 to 3 weeks.No further info is available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device (s) list in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of eval or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.Event date: unk.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH
• 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, dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147480
• MDR Text Key: 4769451
• Report Number: 1000317571-2014-11809
• 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: 07/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/03/2017
• Device Model Number: 411491
• Device Lot Number: 2G00026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2013
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Other
• Patient Weight: 108