MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM PCH CLD MED TAN 40MM (1X30PK) DE; POUCH, OSTOMY

Model Number 404666

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Date 09/20/2011

Event Type  Injury  

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, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The lot number could not be obtained therefore, a review of the batch record data could not be performed without a valid lot number.A review of the complaint listing for the previous 12 months for the product icc codes indicates that there was one case registered for this complaint issue rash/itch under mass/border.No events or capas relating to the complaint issue were found.

Event Description

Report received indicated that end-user developed a rash/itch under mass border while using the product.The patient experienced the condition during an unknown period prior to complaint receipt.Patient outcome was not reported.

• Brand Name: ESTEEM PCH CLD MED TAN 40MM (1X30PK) DE
• Type of Device: POUCH, OSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire ; UK
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4072518
• MDR Text Key: 19371905
• Report Number: 1000317571-2014-10230
• 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
• Type of Report: Initial
• Report Date: 09/20/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention