MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC, INC. ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 400598

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Burning Sensation (2146)

Event Type  Injury  

Event Description

Report received indicated patient applied pouch to clean dry skin and within an hour had itching burning.Patient removed the pouch and noticed the area red and itchy under the mass.The end user's subsequent outcome was not reported.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial, haina; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director, post ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4132825
• MDR Text Key: 20756484
• Report Number: 9618003-2014-11740
• 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: 06/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2013
• 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): Other