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

Model Number 175782

Device Problems Inadequacy of Device Shape and/or Size (1583); Increased Sensitivity (2535)

Patient Problems Increased Sensitivity (2065); Skin Irritation (2076)

Event Date 06/16/2014

Event Type  Injury  

Event Description

It is reported that the end-user developed redness to the left lower quadrant (llq) of abdominal skin after one (1) to three (3) days of use.This redness is described as being one half inch (1/2") encircling the retracted stoma associated with end-user's surgical procedure in march; end-user is unable to visualize stoma due to depth of retraction.It is further reported that end-user sought treatment in the emergency room (er) approximately 105 weeks ago, and then consulted the family physician who administered cipro, flagyl and a narcotic (name unknown) to treat affected site.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.It is reported that skincare is performed as follows: currently using zest soap and performing crusting techniques/procedures.It is further reported that end-user was advised to use a non-residue soap; to re-size barrier as current opening precut to 35 mm and stoma opening is 25mm.Lastly, samples sent to end-user.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.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

Manufacturer Narrative

The product associated with batch 3g01355 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.(b)(4).No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on march 14, 2016.(b)(4).

• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 3976225
• MDR Text Key: 4748533
• Report Number: 1049092-2014-00326
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2018
• Device Model Number: 175782
• Device Catalogue Number: 175782
• Device Lot Number: 3G01355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 100