MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1PC DRAINABLE POUCH W/DRAINABLE+; POUCH, COLOSTOMY

Model Number 400598

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Irritation (1941); Fluid Discharge (2686)

Event Date 12/16/2013

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.It is reported that the issue was resolved with the use of hydrocortisone cream and oral antibiotics, and end-user has now gone back to using regular pouches ((b)(4) one-piece pre-cut drainable pouch with (b)(4) skin barrier transparent with one-side panel and tape collar - size 25mm 1") with weartime of six (6) days.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

Event Description

It is reported that end-user tried product on abdominal skin directly around stoma, and immediately experienced leakage with skin irritation described as bright redness and weeping located under wafer's mass for approximately two (2) to three (3) weeks.

• Brand Name: ACTIVELIFE 1PC DRAINABLE POUCH W/DRAINABLE+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal ; DR
• Manufacturer Contact: mary szaro, associate dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3594826
• MDR Text Key: 15881610
• Report Number: 9618003-2014-00007
• Device Sequence Number: 1
• Product Code: EXB
• 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: 12/16/2013

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: 400598
• Device Catalogue Number: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/13/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 98