MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH - APS; POUCH, COLOSTOMY

Model Number 416742

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074)

Event Date 07/18/2013

Event Type  Injury  

Event Description

Per the end user, their skin is red and itchy within 24 hours of when use started.Cleans with soap and water before applying wafer.No further information is available.

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: ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH - APS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147105
• MDR Text Key: 4933770
• Report Number: 1049092-2014-11841
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2017
• Device Model Number: 416742
• Device Lot Number: 2G00620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Other
• Patient Weight: 50