MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC-1PC DRINABLE POUCH W/ (SH); POUCH, COLOSTOMY

Model Number 022771

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Urticaria (2278)

Event Type  Injury  

Event Description

Report provided by the end user states that he has experienced redness under the mass and border of this pouch.As time passed, the redness became worse under the tape collar.He has live like areas under his tape collar.He does experience itching and burning from this area.He usually changes his pouch every 3-4 days.He uses a paste, a powder, and then barrier wipes to his peristomal skin.He cleanses his peristomal skin with water and occasionally an antibacterial soap.The pt's 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 add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of eval or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.Event date: unk.Device manufacture date: unk.

• Brand Name: ACTIVELIFE 1PC-1PC DRINABLE POUCH W/ (SH)
• Type of Device: POUCH, COLOSTOMY
• 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 avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4040033
• MDR Text Key: 4804856
• Report Number: 9618003-2014-10815
• 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,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• 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
• Date Manufacturer Received: 07/18/2012
• 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: 64