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

Model Number 125354

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

Patient Problems Foreign Body Reaction (1868); Skin Irritation (2076); Fungal Infection (2419)

Event Date 03/01/2015

Event Type  Injury  

Event Description

The end user reported she developed weeping and skin irritation beneath her skin barrier in (b)(6) 2015.On (b)(6) 2015, she sought treatment from a physician who diagnosed the skin irritation as a yeast infection.The end user was prescribed oral fluconazole 150 mg.The end user is taking the prescription medication and also applying stomahesive powder to the affected skin.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(6).

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH
• 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: 4951521
• MDR Text Key: 6636490
• Report Number: 1049092-2015-00443
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• 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
• Treatment: NOT PROVIDED
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 46