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

Model Number 175782

Device Problem Human-Device Interface Problem (2949)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Event Description

The pt reported they developed a red, open rash under the device mass toward the bottom of the stoma.The affected area is approximately 1 inch by 3 inches and has persisted for approximately 2 weeks.The pt is reportedly using anti-inflammatory spray, previously prescribed by the physician.No leakage of stool.Pt changes device every 4-5 days.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized 05/2011.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 april 16, 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
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC; greensboro NC
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059272
• MDR Text Key: 22143917
• Report Number: 1049092-2014-10425
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 01/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175782
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73