MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM PCH CLD MED TAN 35MM; POUCH, COLOSTOMY

Model Number 404798

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

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Complaintant reports "very difficult to remove pouch off - left skin bleeding and red raw - remover wipes did not help.".

• Brand Name: ESTEEM PCH CLD MED TAN 35MM
• 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 ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289321
• MDR Text Key: 33273460
• Report Number: 1000317571-2015-40067
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• 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: Lay User/Patient
• Device Expiration Date: 04/05/2016
• Device Model Number: 404798
• Device Lot Number: 1D00515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2011
• 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