MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC DRAINABLE POUCH W/ STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022771

Device Problem Insufficient Information (3190)

Patient Problem Fungal Infection (2419)

Event Date 09/25/2013

Event Type  Injury  

Event Description

Spouse of end user reported that the end user had yeast infection around incision in the hospital.Yeast traveled across abdomen and under the tape border.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user's wound ostomy continence nurse suggested nystatin powder and 3m non sting protective barrier.The end user continues to use these products; skin improving.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1PC DRAINABLE POUCH W/ STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, stobal 3310 2; DR 33102
• Manufacturer Contact: mary szaro, associate dir ; 200 headquarters park dr; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3581054
• MDR Text Key: 17389668
• Report Number: 9618003-2014-00006
• Device Sequence Number: 1
• Product Code: EXB
• 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: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Device Catalogue Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• 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: 115