MAUDE Adverse Event Report: CONVATEC INC. S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH; PROTECTION, OSTOMY

Model Number 404593

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

Report provided by the end user reported an itchy red bumpy rash under entire skin barrier and extended behind the pouch.Patient admitted the application of a skin barrier on the skin and was not aware appliance was moldable.As a result patient experienced leakage after days of wear.Patient intended to contact her doctor for treatment and was advised that appliance is best adhered if a powder or liquid medication is first applied to the skin.The end user subsequent outcome was not reported.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4)2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH
• Type of Device: PROTECTION, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director post ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4132835
• MDR Text Key: 17164593
• Report Number: 1049092-2014-11749
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 45