MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC. ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ STOMAHESIVE (SH); POUCH, COLOSTOMY

Model Number 022766

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

Patient Problems Skin Irritation (2076); Blood Loss (2597)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced leakage toward her umbilicus, has denuded skin from 3:00 to 6:00 extending outward approximately 50mm.This denuded area bleeds a moderate amount when the appliance is changed.No bleeding noted at this time.The end user has been changing the pouch at least daily up to multiple times per day.The end user uses adhesive remover to her peristomal skin to help remove the white tape collar.She cleanses her peristomal skin with soap or an cleansing foam, ostomy powder, followed a protective barrier wipes or spray.The end user uses an ostomy paste to her peristomal skin.Advised the end user to contact her health care provider.Instructed on cleansing her peristomal skin with water and mild soap; one without lotions; moisturizers or creams.Instructed if area does not improve or she has any questions to contact us for additional instructions.Recommend moldable skin barrier.The end users subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Devices listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ STOMAHESIVE (SH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC.; carretera sanchez, km. 18.5; parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4106098
• MDR Text Key: 4839928
• Report Number: 9618003-2014-11476
• 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: 03/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2017
• Device Model Number: 022766
• Device Lot Number: 2J00061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 106