MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/DURAHESIVE (DH) PLUS; POUCH, COLOSTOMTY

Model Number 125331

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a rash under the tape border at the bottom only.It is red and itchy and has a yeasty odor.The end user has applied a calamine and aloe ointment both under and over the tape border and has also tried applying a barrier wipe to the skin.The end user had seen her primary care provider about this in the past and was given clotrimazole and betamethasone ointment but was unable to keep the appliance in place and so stopped using.It was discussed with the end user the use of powered medication for application under appliance and allowing air to get to the skin behind the pouch by using soft fabric in hot weather between pouch and skin.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 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 DRAINABLE POUCH W/DURAHESIVE (DH) PLUS
• Type of Device: POUCH, COLOSTOMTY
• Manufacturer (Section D): CONVATEC DOMINICAN 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: 4117921
• MDR Text Key: 4840088
• Report Number: 9618003-2014-11704
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K83362
• 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: 06/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 125331
• Device Lot Number: 2J02729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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