MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Per the end user, circumferential red rash under the tape collar of the pouch.Changes pouch every day.Uses ostomy gel with each pouch change and adhesive remover as needed for adhesive buildup.Cleans peristomal skin with soap.No further information is available.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 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.The submission of this report by convatec or related information to the fda and its release by the fda, does not reflect an admission by convatec, or a conclusion by the fda that this report or related information that convatec, their employees, or the convatec device caused or contributed to the reportable event.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.It is noted that there are blank areas on this form, the information was not provided or is unknown.

• Brand Name: ACTIVELIFE 1PC - 1 PC DRAINABLE POUCH
• 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 ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4135814
• MDR Text Key: 4928333
• Report Number: 9618003-2014-10278
• 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: 10/19/2011

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 Expiration Date: 07/05/2016
• Device Model Number: 022771
• Device Lot Number: 1F03590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2011
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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: 66