MAUDE Adverse Event Report: CONVATEC, INC ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE; POUCH, COLOSTOMY

Model Number 175780

Device Problem Leak/Splash (1354)

Patient Problem Hyperplasia (1906)

Event Type  Injury  

Event Description

The end user developed hyperplasia or peristomal skin as a result of leakage from her wafer.An ostomy nurse started removal of the hyperplasia by using silver nitrate.It was also noted there was a small amount of bleeding from removing the hyperplasia.Advised to use stomahesive powder and barrier wipes to crust weeping hyperplasia.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No add'l pt/event details have been provided to date.Should add'l info become available a follow up report will be submitted.

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4395757
• MDR Text Key: 5430362
• Report Number: 1049092-2015-00008
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 175780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR