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

Model Number 404593

Device Problem Human-Device Interface Problem (2949)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

It was reported that approx two months ago user developed a red, open, weepy rash to under 100 percent of the tape collar.Applied an over the counter powder without any improvement.Pt 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, no 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 eval or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trend.

• Brand Name: S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH)
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir, engineer ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4135778
• MDR Text Key: 4915876
• Report Number: 1049092-2014-10395
• 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: 12/08/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2016
• Device Model Number: 404593
• Device Lot Number: 1H02951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70