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

Model Number 413181

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 06/05/2011

Event Type  Injury  

Event Description

Report received indicated that the pt, during the last month, started to develop a red dotted rash that appeared like mosquito bites under the tape collar in a scattered pattern, from 3 to 9 o clock.The pt has been using sh powder and eakin seals on the skin under the skin barrier.It was also noted that the pt's doctor is to call in antifungal powder.The subsequent outcome of the pt was not reported.

Manufacturer Narrative

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 2 PC - 2 PC DURAHESIVE (DH) CONVEX WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew walenciak, dir, post mark ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4020754
• MDR Text Key: 15107951
• Report Number: 1049092-2014-10109
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• 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: 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: 05/03/2016
• Device Model Number: 413181
• Device Lot Number: 1D02848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59