MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA 2 PC CLOSED END POUCH; POUCH, COLOSTOMY

Model Number 125907

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation (2443)

Event Date 08/22/2014

Event Type  Injury  

Event Description

It is reported the end-user developed an inflammation, possibly a fungal infection around her stoma under the wafer and pouch approximately one (1) week ago and needs the wafer changed daily.

Manufacturer Narrative

The nurse tried using bifonazole cream without improvement.The physician is scheduled to see the end-user next week.As an additional note, the end-user resides in an elderly care home and has used the product for many years.Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of report.A return sample for evaluation is not expected.The lot number was not provided.Should additional information become available, a follow-up report will be submitted.

• Brand Name: SUR-FIT NATURA 2 PC CLOSED END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4106431
• MDR Text Key: 16447153
• Report Number: 9618003-2014-00084
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 125907
• Device Catalogue Number: 125907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention