MAUDE Adverse Event Report: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH)

Model Number 175777

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

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Event Description

Report received from a family member (daughter) indicated that patient had developed an infection of the stoma.It was also reported that the patient was experiencing leakage and scalding of the skin around the right lower area of the stoma.The infection had progressed causing weeping and fluid (blood) to protrude.Prior to the receipt of this complaint the patient used the pouch for several years without incident.Additional info was provided stating that "after using ointments and dressing on the infection, the area is still inflamed and reddened but showing signs of improvement.She was advised to use stomahesive powder and alternative products to reduce redness." further info regarding patient outcome was not provided.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16 2014.Device listed in this report is used for treatment, not diagnosis.And additional info 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: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH)
• Manufacturer (Section D): CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4083778
• MDR Text Key: 20291955
• Report Number: 1049092-2014-10756
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• 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: 06/18/2012

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 Model Number: 175777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2012
• Initial Date FDA Received: 08/22/2014
• 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: 48