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

Model Number 125354

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

Patient Problems Wound Dehiscence (1154); Increased Sensitivity (2065); Skin Inflammation (2443)

Event Date 05/01/2013

Event Type  Injury  

Event Description

It is reported that the end-user, who have used this product for ten (10) years, right lower quadrant (rlq) of abdominal skin presented as red, open, and weepy with foul smelling drainage under the ostomy tape collar.It is further reported that several months ago, the end-user was evaluated by her physician who prescribed topical nystatin powders to treat peristomal skin with no signs of improvements.About one (1) month ago, end-user was seen by a health care provided (hcp) who prescribed oral diflucan with no signs of improvements.Lastly, end-user was advised to arrange for a visit with health care provided (hcp) if the issue persists or becomes worse.

Manufacturer Narrative

Based on the available information, this event is being reported as a serious injury.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 23, 2014.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/DURAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3987328
• MDR Text Key: 4636913
• Report Number: 1049092-2014-00330
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125354
• Device Catalogue Number: 125354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• 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: 59