MAUDE Adverse Event Report: CONVATEC DOM REPUBLIC, INC. ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOM; POUCH OSTOMY

Model Number 022771

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

Report received indicated patient received a rash and itching under the mass around the stoma and peristomal skin.According to report patient wore device every 3 to 4 days.Patient family member indicated that the skin was washed with water, patted dry and applied with an ointment prior to application of the appliance.Patient was instructed the use of powder and barrier wipe for crusting prior to the application of the appliance.Patient was issued samples.The end user's 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 from a trending report of evaluations 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.Brand name: sur-fit natura durahesive flexible skin barrier w/flange w/white tape collare and cut-to-fit opening (overall dimension 4" x 4").

• Brand Name: ACTIVELIFE 1 PC - 1 PC DRAINABLE POUCH W/STOM
• Type of Device: POUCH OSTOMY
• Manufacturer (Section D): CONVATEC DOM REPUBLIC, INC.; carr sanchez, km. 18.5; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409
• MDR Report Key: 4135760
• MDR Text Key: 4914823
• Report Number: 9618003-2014-11742
• 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: 06/14/2013

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 Model Number: 022771
• Device Lot Number: 3B00641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2014
• Initial Date FDA Received: 09/29/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 73