MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISITAN60/70MM; POUCH, COLOSTOMY

Model Number 416719

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Skin Irritation (2076)

Event Date 05/17/2012

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).(b)(4).

Event Description

Complainant reports "adhesive is too aggressive and ,when the pouch is removed, leaves reddened skin.".

• Brand Name: ESTEEM PCH DRNWFINVISITAN60/70MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289393
• MDR Text Key: 33275775
• Report Number: 9618003-2015-40073
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Model Number: 416719
• Device Lot Number: 1J02837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• 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: Unknown
• Patient Sequence Number: 1