MAUDE Adverse Event Report: CONVATEC LIMITED S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH W/ FILTER; POUCH, SOLOSTOMY

Model Number 411290

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Date 05/30/2011

Event Type  Injury  

Event Description

Report received indicated the pt experienced a worsening red, itchy rash underneath the entire pouch film with satellite red areas.The pt experienced the condition during a period of 2 weeks prior to complaint receipt.Treated with skin prep and stomahesive powder and skin barrier.Advised to place pouch above undergarment rather than against skin.Advised pouch cover and evaluation for yeast.Pt outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.Item not returned, lot number not known.A review of the complaint listing for the previous 12 months for this product icc codes indicates that this was the only case register for rash under pouch film.No events or capa's relating to the complaint issues were found in the global non-conformance reporting system for the previous 12 months of case creation.

• Brand Name: S2S/SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH W/ FILTER
• Type of Device: POUCH, SOLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, dir. post mark ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4057872
• MDR Text Key: 4906763
• Report Number: 1000317571-2014-10094
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 411290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2011
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Weight: 54