MAUDE Adverse Event Report: CONVATEC INC. ESTEEM + DRAINABLE POUCH EXTENDED WEAR, (64MM; POUCH, COLOSTOMY

Model Number 416975

Device Problem Difficult to Remove (1528)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Event Description

The end user reported upon removal, the colostomy pouch was difficult to remove.The end user further noted her skin was red after removal.No additional information was provided.

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.

• Brand Name: ESTEEM + DRAINABLE POUCH EXTENDED WEAR, (64MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal ; DR
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4652182
• MDR Text Key: 20016467
• Report Number: 9618003-2015-00012
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• 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: 55 YR