MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1PC01PC UROSTOMY CONVEX W/DURAHESIVE (DH); POUCH, COLOSTOMY

Model Number 175782

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

Report provided by the end user states that they have experienced a red rash upon removing the product.The pts 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 add'l info received regarding this event after filling this report shall be filed on a supplemental mdr.It is noted that there are blank areas on this form, the info was not provided or is unk.Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1PC01PC UROSTOMY CONVEX W/DURAHESIVE (DH)
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir., engineer ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4084763
• MDR Text Key: 4739188
• Report Number: 1049092-2014-11412
• Device Sequence Number: 1
• Product Code: EXB
• 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: 02/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/24/2017
• Device Model Number: 175782
• Device Lot Number: 2F02186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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): Required Intervention