MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC. S4S/SUR-FIT NATURA 2PC-2PC CLOSED END POUCH W/FILTER; POUCH, COLOSTOMY

Model Number 413174

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 05/20/2013

Event Type  Injury  

Event Description

Report provided by the wife of the end user states that the end user has developed a red, raised, bumpy scattered rash under the bottom of pouch near the groin.The end user is to have his medical doctor order an anti fungal powder.The end users subsequent 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.The case narrative was reviewed.There were no reportable issues found in the narrative.No product return was received.There were no non conformances raised for this product during the previous 12 months.The quality systems in place are appropriate to prevent this defect from occurring or defect this defect in the event of occurrence.This complaint will be closed.Future complaints will be monitored for trends.

• Brand Name: S4S/SUR-FIT NATURA 2PC-2PC CLOSED END POUCH W/FILTER
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC.; carr sanche, km 18.5; parque industrial; haina, san cristobal 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4135780
• MDR Text Key: 4927833
• Report Number: 9618003-2014-11709
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/10/2013

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 Model Number: 413174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention