MAUDE Adverse Event Report: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH; POUCH, COLOSTOMY

Model Number 416742

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The patient reported the device mass is difficult to remove.The patient has tried incorporating adhesive remover; however, the problem persists.No patient complications were reported as a result of this event.

Manufacturer Narrative

A review of process records for lot 1k02015 revealed no non-conforming process samples.Product was produced according to validated quality and manufacturing procedures.Components were approved for use per quality system requirements.Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 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.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4098413
• MDR Text Key: 4717816
• Report Number: 1049092-2014-11095
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2016
• Device Model Number: 416742
• Device Lot Number: 1K02015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1