MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC-1PC CLOSED END POUCH; POUCH, COLOSTOMY

Model Number 062449

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

Patient Problem Skin Irritation (2076)

Event Date 02/27/2013

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a skin breakdown under mass.The end user was sent a sample of a two piece ostomy device, to reduce stress on the skin when changing pouches.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 april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filling this report shall be filed on a supplemental mdr.It is noted that there are blank areas on this form, the info was not provided or is unk.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: ACTIVELIFE 1PC-1PC CLOSED END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir., engineer ; 211 american ave.; greensboro, NC 2749 ; 9083779293
• MDR Report Key: 4084782
• MDR Text Key: 16562255
• Report Number: 9618003-2014-11418
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Type of Report: Initial
• Report Date: 02/27/2013

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: 062449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2013
• Initial Date FDA Received: 09/04/2014
• 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