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

Model Number 125352

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

Patient Problems Rash (2033); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Height: 59 inches.Based on the available information, this event is deemed to be a serious injury.No corrective action exists for this complaint issue.A complaint query was generated from the date range of (b)(6) 2014 to (b)(6) 2015 and the results of the query identified a total of (b)(4) complaints for the product reported.As a result there were (b)(4) complaints associated with icc code# (b)(4) and no conclusion could be determined.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Consumer reports a rash which is scattered under the mass, tape collar, and outside of tape collar.It is bleeding in spots.Physician prescribed nystatin powder and diflucan for yeast infection.

• Brand Name: ACTIVELIFE® CONVEX ONE-PIECE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6111815
• MDR Text Key: 60281342
• Report Number: 1049092-2016-00479
• 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: Patient
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• 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: MEDICATION FOR DEPRESSION (BRAND NOT PROVIDED); NEXIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66