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

Model Number 022771

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

Patient Problem Skin Discoloration (2074)

Event Date 11/30/2012

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced redness around the peristomal skin after using a specific ostomy paste and barrier wipes.The end user is undergoing radiotherapy.The condition getting more severe after the 2nd week.According to customer, he is also allergy to petroleum products.Pt was put on stomadress, no stomahesive paste or convatec barrier wipes were used.The pts subsequent outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, no diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of eval or adverse events finalized may 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 Contact: matthew walenciak, dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4125080
• MDR Text Key: 18288811
• Report Number: 9618003-2014-11128
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/30/2012

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 Expiration Date: 04/23/2017
• Device Model Number: 022771
• Device Lot Number: 2D02152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2012
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention