MAUDE Adverse Event Report: CONVATEC INC S4S-SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER; PROTECTOR, OSTOMY

Model Number 411804

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 06/20/2011

Event Type  Injury  

Event Description

Report received indicated that the pt has itchiness and red pimples under the border tape.It started 2 weeks prior to the initial report.Initially, the pt was applying allkare protective barrier wipes, then she stop using it.She is no using water and soap and has less itchiness.She had made no change in her medication.The pt's subsequent outcome was not reported.

Manufacturer Narrative

It is noted that there are blank areas on this form, the info was not provided or is unk.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 DURAHESIVE (DH) MOLDABLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew walenciak, dir, most mark ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4020756
• MDR Text Key: 4842953
• Report Number: 1049092-2014-10108
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/04/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/15/2016
• Device Model Number: 411804
• Device Lot Number: 1B01722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2011
• 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