MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE CONVEX 1-PIECE PRE-CUT DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 175778

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

Patient Problem Skin Irritation (2076)

Event Date 08/18/2003

Event Type  Injury  

Event Description

The pt reported she recently developed occasional "red splotchy" areas under the device mass.The affected area seems to get worse when the pt consumes certain foods; specifically, tomato based or acid based foods.The pt has reportedly been using the same brand and model of device since 2004 with no problems.Allegedly, the affected area clears when the pt discontinues use of the current device, opting for a different brand and model.No further info was reported.

Manufacturer Narrative

Analysis is taken from a trending report of evaluation or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Brand name: activelife convex 1-piece pre-cut drainable pouch w/ durahesive skin barrier w/ 1-sided comfort panel and tape collar 12" transparent.

• Brand Name: ACTIVELIFE CONVEX 1-PIECE PRE-CUT DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; greensboro NC
• Manufacturer Contact: matthew walenciak, dir ; med safety & compliance; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4125043
• MDR Text Key: 4949148
• Report Number: 1049092-2014-11018
• 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: 10/16/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2012
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 74