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

Model Number 402202

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

Report received indicated the pt has a rash under the border.No additional information was provided and pt outcome 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.It is noted that there are blank areas on this form.

• Brand Name: S4S/SUR-FIT NATURA 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, ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4058339
• MDR Text Key: 4865862
• Report Number: 1049092-2014-10529
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 03/02/2012

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 Model Number: 402202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2012
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention