MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM INVISI DRN MEDCLRWFBSF20MM; POUCH, COLOSTOMY

Model Number 411228

Device Problem Difficult to Remove (1528)

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

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation (b)(4).

Event Description

End-user reported that adhesive has become difficult to remove from the skin, advised this is recently happened.

• Brand Name: ESTEEM INVISI DRN MEDCLRWFBSF20MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first ave; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5156060
• MDR Text Key: 28487510
• Report Number: 1000317571-2015-30641
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 411228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• 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: Unknown
• Patient Sequence Number: 1