MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1PC UROSTOMY POUCH W/DURAHESIVE; URINARY, ILLEOSTOMY

Model Number 650830

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

Patient Problem Rash (2033)

Event Date 03/17/2014

Event Type  Injury  

Event Description

It was reported the end user stated he "has had a full rash under whole of wafer and mass.It has been there for one month.".

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.The end user went on to state "his doctor prescribed cortisone pills which cleared up rash." discontinued medication one week ago and now rash is back.No additional patient event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1PC UROSTOMY POUCH W/DURAHESIVE
• Type of Device: URINARY, ILLEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int, ass dir ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3824462
• MDR Text Key: 4403341
• Report Number: 1049092-2014-00101
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800495
• 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: 04/09/2014

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: 650830
• Device Catalogue Number: 650830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/08/2014
• 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): Required Intervention
• Patient Weight: 78