MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM® + ONE-PIECE DRAINABLE PRE-CUT POUCH W/ INVISICLOSE® MODIFIED STOMAHESIVE; POUCH, COLOSTOMY

Model Number 416728

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Event Description

The end user's spouse reported the one-piece pouch and skin barrier was difficult for the end user to remove after three days of wear.The end user did not use any adhesive removing products to aid in pouch removal.No patient consequences were reported as a result of this event.

• Brand Name: ESTEEM® + ONE-PIECE DRAINABLE PRE-CUT POUCH W/ INVISICLOSE® MODIFIED STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; lot 30 - piisa industrial park; carretera sanchez km. 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5177772
• MDR Text Key: 29242476
• Report Number: 9618003-2015-00059
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR