MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/ DURAHESIVE (DH); POUCH, COLOSTOMY

Model Number 175781

Device Problem Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated patient developed three pimples under wafer which progressed into the reddening of the peristomal skin area.The report also noted the redness and symptoms "comes and goes." prior to the receipt of this complaint, the patient used the product for several years without incident.The product is changed every three to four days and then cleaned using alcohol and barrier wipes.Patient saw physician who administered silver nitrate to the infection and recommended use of an alternative product.The manufacturer sent alternative product for use and the patient was advised to consult with physician regarding further medical treatment if symptoms did not improve.Further information regarding patient results were not 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) 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 (b)(4) 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)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4072454
• MDR Text Key: 4832493
• Report Number: 1049092-2014-10787
• 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: 06/29/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2012
• 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: 89