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

Model Number 175793

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

Patient Problem Rash (2033)

Event Date 10/24/2012

Event Type  Injury  

Event Description

It was reporting the pt developed a red rash under the tape border of the device.No further info was provided.

Manufacturer Narrative

Analysis is taken from a trending report of evaluation or adverse events finalized (b)(6) 2011.The data presented is from three different product applications.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Brand name: activelife convex 1-piece pre-cut urostomy pouch w/ durahesive skin barrier - transparent standard.

• Brand Name: ACTIVELIFE CONVEX 1-PIECE PRE-CUT UROSTOMY POUCH W/ DURAHESIVE SKIN BARRIER
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; greensboro NC
• Manufacturer Contact: matthew walenciak, dir ; med safety & compliance; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4125047
• MDR Text Key: 4792744
• Report Number: 1049092-2014-11034
• Device Sequence Number: 1
• Product Code: EXH
• 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
• Type of Report: Initial
• Report Date: 10/24/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: 175793
• Device Lot Number: 2E02785
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2012
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 84