MAUDE Adverse Event Report: CONVATEC INC. S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) FLEXIBLE WAFER; BAG, URINARY, ILEOSTOMY

Model Number 413181

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

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a rash under the tape border only and most noted from 3 to 6 o'clock.The area is red bumpy weeping and very itchy.Because of the weeping the tape border is lifting.Initially treated with ostomy powders.The end user has been seen by her doctor, her home healthcare nurse and the home healthcare wocn.Discussed how to patch test.Advised the end user to cut the tape border off before applying and to use hypo allergenic tape to secure the test products away from the stoma prior to using.The patient's subsequent outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 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 2PC-2PC DURAHESIVE (DH) FLEXIBLE WAFER
• Type of Device: BAG, URINARY, ILEOSTOMY
• 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: 4128012
• MDR Text Key: 4938691
• Report Number: 1049092-2014-11136
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 12/04/2012

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: 10/15/2017
• Device Model Number: 413181
• Device Lot Number: 2J02182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2012
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention