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

Model Number 104593

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 11/24/2011

Event Type  Injury  

Event Description

Report received indicated that customer reported "intact rash under both wafer and tape collar extending outward 1 inch".The patient experienced the condition during a period of four days prior to complaint receipt.Customer is using adhesive remover; soap; and skin prep with belt.Patient 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 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 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 2PC - 2PC DURAHESIVE (DH)
• Manufacturer (Section D): CONVATEC, INC.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053554
• MDR Text Key: 4731290
• Report Number: 1049092-2014-10367
• 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: 11/28/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2016
• Device Model Number: 104593
• Device Lot Number: 1E01038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2011
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86