MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. SUR-FIT NATURA STOMAHESIVE SKIN BARRIER W/ FLANGE W/O TAPE COLLAR AND W/ CUT-TO; POUCH, COLOSTOMY

Model Number 022771

Device Problems Leak/Splash (1354); Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Patient reported there has been a problem with stool leaking under the skin barrier.As a result skin appears red and sore all around the stoma and patient also reported some small red growths of tissue on the skin at the edge of retracted stoma.Patient admits frequent bleeding of the skin and pouch is unable to adhere.Patient was recommended to see wocn for proper fitting, was advised to keep stool off skin to encourage proper skin healing.Discussed use of powder and water to crust.Discussed bleeding in affiliation to anti-coagulant medication.Samples were issued to patient.The end user subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device (s) listed in this report is (are) used for treatment, no diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Brand name: sur-fit natura stomahesive skin barrier w/ flange w/o tape collar and w/ cut-to-fit opening (overall dimension 4" x 4").Analysis is taken from a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: SUR-FIT NATURA STOMAHESIVE SKIN BARRIER W/ FLANGE W/O TAPE COLLAR AND W/ CUT-TO
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147514
• MDR Text Key: 4769993
• Report Number: 9618003-2014-11762
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/19/2013

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: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2013
• Initial Date FDA Received: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 85