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

Model Number 404593

Device Problem Human-Device Interface Problem (2949)

Patient Problems Irritation (1941); Skin Irritation (2076)

Event Date 05/17/2011

Event Type  Injury  

Event Description

Report received from the end user stating she developed a sore area under the wafer and tape border.It is red and weeps sometimes and feels sore.It is about 4 cm x 3 cm.She has had reduced weartime since this developed.She saw her wound care nurse in (b)(6) and was instructed to apply powder, then spray with a spray and apply a flat 2 piece appliance.Pt was advised to discontinue the product for now.Pt was sent appropriate products and instructed how to use powder and h2o instead of spray, pt will see wound care nurse if no improvement is noticed.The pts subsequent 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 add'l info 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 DURAHESIVE (DH) CONVEX MOLDABLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir, post mark ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4051695
• MDR Text Key: 4907751
• Report Number: 1049092-2014-10179
• Device Sequence Number: 1
• Product Code: EXB
• 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,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/17/2011

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: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2011
• Initial Date FDA Received: 08/08/2014
• 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
• Patient Weight: 68