MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1-PIECE PRE-CUT CLOSED-END POUCH W/SKIN BARRIER & FILTER W/1-SIDED CO; POUCH, COLOSTOMY

Model Number 175771

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Event Description

The patient reported circumferential redness under the mass of her device.The redness is located approximately 25 mm from the edge of the mass with no redness near the stoma.The red area has persisted for approximately 3-4 months prior to receipt of complaint.The patient indicated the affected area does itch and occasionally bleeds and has tried to treat the affected area with a number of over-the-counter medications to no avail.The patient is reportedly changing the device 2-3 times per day.The patient sought medical treatment from her local physician and was referred to a wound specialist.Although the patient has followed the course of treatment recommended by the would specialist, the redness, itching and occasional bleeding continue.No further information noted regarding outcome of patient.

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 from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from (b)(4) different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1-PIECE PRE-CUT CLOSED-END POUCH W/SKIN BARRIER & FILTER W/1-SIDED CO
• 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, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4072301
• MDR Text Key: 4745715
• Report Number: 9618003-2014-11027
• 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: 10/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 82