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

Model Number 022771

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

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

Event Type  Injury  

Event Description

The patient's home health nurse reported the redness and denudement of skin under the stomahesive and tape collar.Some wetness was noted underneath the ostomy mass and border.No further information was 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 issues 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 DOM. REPUBLIC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, dir. post mark ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4067991
• MDR Text Key: 4897545
• Report Number: 9618003-2014-10472
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2012
• 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: 54