MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 400598

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported the patient has developed a rash under both the mass and the tape collar of the device.The rash is red, itchy and shiny with tiny blisters.According to the patient's wife, the rash has persisted for approximately 1 month and initially began while the patient was using another manufacturer's device.The patient presented to his physician and was reportedly diagnosed with candidiasis.He was advised to use lotrisone ointment and has seen some improvement.No further patient complications were reported.

Manufacturer Narrative

A review of the batch record and retain evaluation could not be performed without a lot number.A review of complaints for previous 12 months was performed and there is no indication of complaint trend based on this review.Based on the investigation conducted, the complaint could not be confirmed.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.

• Brand Name: ACTIVELIFE 1-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; san cristobal, haina
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059328
• MDR Text Key: 4906859
• Report Number: 9618003-2014-10491
• 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: 02/17/2012

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: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2012
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 96