MAUDE Adverse Event Report: CONVATEC INC. S4S/SUR-FIT NATURA 2 PC- 2 PC STOMAHESIVE,S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE; COLLECTOR, OSTOMY

Model Number 125260

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Date 05/24/2011

Event Type  Injury  

Event Description

Report received indicated the patient experienced an intermittent rash under the adhesive border.The patient experienced the condition during a period of five years prior to complaint receipt.Recommended non-oil soap, stomahesive powder and a protective barrier.Patient outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda (b)(4) issued april 16, 2014.Devices listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.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.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: S4S/SUR-FIT NATURA 2 PC- 2 PC STOMAHESIVE,S4S/SUR-FIT NATURA 2PC-2PC STOMAHESIVE
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3987224
• MDR Text Key: 17574267
• Report Number: 1049092-2014-10043
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830945
• 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: 05/24/2011

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: Lay User/Patient
• Device Expiration Date: 02/24/2016
• Device Model Number: 125260
• Device Lot Number: 1B01727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2011
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 102