MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC. ACTIVELIFE 1PC-1PC DRANIABLE POUCH W/DURAHEISVE (DH) PLUS; POUCH, COLOSTOMY

Model Number 400599

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

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Date 05/16/2013

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced redness, and now a denuded area at the 6 o'clock portion of the peristomal skin under the mass with no other areas of redness.The end user reports that the stoma is oval in shape, noting that it is also tilting downward at the 6 o'clock area.The end user has been cutting a round, 38mm, opening in the pouch.The use of an ostomy powder was discussed with the end user and alternate appliance samples are being sent.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, 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: ACTIVELIFE 1PC-1PC DRANIABLE POUCH W/DURAHEISVE (DH) PLUS
• 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: 4117930
• MDR Text Key: 4836080
• Report Number: 9618003-2014-11698
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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: 06/06/2013

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 Expiration Date: 11/01/2014
• Device Model Number: 400599
• Device Lot Number: 2L02616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2013
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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