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

Model Number 411802

Device Problem Human-Device Interface Problem (2949)

Patient Problem Skin Irritation (2076)

Event Date 09/22/2011

Event Type  Injury  

Event Description

The report received indicated that the patient had a small wound developed at the muco cutaneous border at about 2 o' clock.It is small about 1 cm long with pink moist wound bed.Is painful and does burn when using wipes or cleaning.The patient experienced the condition during an unknown period prior to complaint receipt.Patient outcome was not reported.

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 (b)(4) 2011.The data presented is from 3 different product applications.The report states that there are no significant trends.

• Brand Name: S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) MOLDABLE WAFER
• Type of Device: COLLECTOR, OSTOMY
• 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: 4072521
• MDR Text Key: 4739362
• Report Number: 1049092-2014-10239
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/26/2011

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: 411802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2011
• Initial Date FDA Received: 08/29/2014
• 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: 86