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

Model Number 125355

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

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Event Description

Report received that end user has redenned, open, weeping area since may of 2012.Has used lotrimin spray on area under durahesive barrier without positive results.The area affected is under the durahesive barrier only.It does not extend passed the tape collar.Further information regarding patient outcome was not available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device(s) 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 may 2011.The data presented is from three different product applications.The report states that there are no significant trends.After further investigation, the initial lot information obtained was determined as invalid under the current system.

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/DURAHESIVE (DH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir., post mar ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4098051
• MDR Text Key: 4718321
• Report Number: 1049092-2014-10783
• 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: 06/29/2012

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 Model Number: 125355
• Device Lot Number: 2B03227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2012
• Initial Date FDA Received: 09/03/2014
• 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): Other
• Patient Weight: 84