MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1PC DRAINABLE POUCH W/ DURAHESIVE; POUCH, COLOSTOMY

Model Number 125354

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Itching Sensation (1943); Burning Sensation (2146); Discharge (2225); Fungal Infection (2419)

Event Date 12/05/2013

Event Type  Injury  

Event Description

An email was received (b)(6) 2013 from the end user regarding a possible fungal infection from 3 to 7 o'clock under wafer and extending out onto the abdominal skin.The end user states that the skin is reddened weepy oozing at times.The end user reported that the skin under wafer is moist and inflamed with light yellow drainage that foul smells with burning and itching.A message was left on the end user's work voicemail requesting for further info.Today customer intake center will continue to attempt to contact.On (b)(6) 2013 spoke to end user and she reconfirmed what was reported earlier, that issue has been occurring since (b)(6) 2013.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end users advised to try and over the counter antifungal powder and crust with productive wipe.The end user reported that she will contact physician for oral antifungal and that she will see her physician in one month.No additional pt/event details have been provided to date.A return sample for eval is not expected.Should additional info become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE 1PC DRAINABLE POUCH W/ DURAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, associate dir ; 200 headquarters park dr; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3570966
• MDR Text Key: 18571132
• Report Number: 1049092-2014-00016
• Device Sequence Number: 1
• Product Code: EZQ
• 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: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125354
• Device Catalogue Number: 125354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2013
• 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: 59