MAUDE Adverse Event Report: CONVATEC DOM REPUBLIC, INC ACTIVIELIFE 1PC-1PC DRAINABLE POUCH W/SH; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Report provided by the end users wife states that the end user has experienced a partial loss of skin thickness from 6:00 to 7:00 o'clock.The end users wife said that the area started out as an open area the size of an eraser head, but continued to increase in size.It now extends from the end users stoma, out toward the end of the tape collar.It was also noted that the end user always has stool on his skin when the barrier is removed, especially at the distal end of the skin barrier.The end user saw his healthcare provider who recommended covering the wound with dry gauze daily and prescribed an antibiotic.The healthcare provider instructed the end user on crusting with an ostomy powder and a skin protective barrier wipe or water.It was also recommended that the end user try a skin barrier with a larger cutting surface.The pts subsequent outcome was not noted.

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 form a trending report of evaluations or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVIELIFE 1PC-1PC DRAINABLE POUCH W/SH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM REPUBLIC, INC; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4121376
• MDR Text Key: 21722997
• Report Number: 9618003-2014-11159
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 12/05/2012

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: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2012
• Initial Date FDA Received: 09/19/2014
• 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: 136