MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1-PIECE PRE-CUT UROSTOMY POUCH W/DURAHESIVE SKIN BARRIER & ACCUSEAL T; URINARY, ILEOSTOMY

Model Number 650831

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

Patient Problem Erythema (1840)

Event Type  Injury  

Event Description

The pt reported red blotchy areas under the device mass.The redness extends approximately three eights of an inch outside of the mass.No drainage.Treated with topical corticosteroid.No further info was reported.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized (b)(6)2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1-PIECE PRE-CUT UROSTOMY POUCH W/DURAHESIVE SKIN BARRIER & ACCUSEAL T
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; medical safety & compliance; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4096426
• MDR Text Key: 4721592
• Report Number: 1049092-2014-11083
• Device Sequence Number: 1
• Product Code: EXH
• 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: 11/14/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2017
• Device Model Number: 650831
• Device Lot Number: 2E2148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: 61