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

Model Number 175778

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

Patient Problem Rash (2033)

Event Date 01/01/2010

Event Type  Injury  

Event Description

The end user reports that sometime in 2010 she developed skin irritation with pinpoint bleeding.She sought treatment from a physician and was issued a prescription for triamcinolone cream.End user stated that she did not use the cream as she knew it would interfere with the pouch seal; instead she changed the appliance more often and the skin irritation healed.

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 f/u report will be submitted.

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walencial, assoc., dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4930941
• MDR Text Key: 6051835
• Report Number: 1049092-2015-00417
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• 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
• Treatment: MULTIVITAMIN; CARVEDILOL; FLUOXETIN LISINOPRIL; FERROUS SULFATE; LOPERAMIDE; VITAMIN B3; CLOPIDROGREL; MEDICATION: ASPIRIN; ATORVASTATIN
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68