MAUDE Adverse Event Report: CONVATEC INC. S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR; NONE

Model Number 125277

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

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated the patient developed a red rash on the peristomal skin under 100 percent of the tape border.The patient tried applying the wafer in a diamond shape, but redness still occurred in a diamond pattern under the tan tape border.There was no redness under the mass.No further information was provided and the patient outcome was not reported.

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 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 may 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 STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR
• Type of Device: NONE
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4117939
• MDR Text Key: 4702258
• Report Number: 1049092-2014-11181
• 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: 12/13/2012

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: 08/02/2017
• Device Model Number: 125277
• Device Lot Number: 2G03173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2012
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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): Other
• Patient Weight: 109