MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC DRAINABLE POUCH; POUCH, COLOSTOMY, 78

Model Number 020922

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

Patient Problem Skin Inflammation (2443)

Event Date 08/03/2014

Event Type  Injury  

Event Description

It was reported by the end user of blisters beneath mass of peristomal skin.

Manufacturer Narrative

Based on the available info this event is deemed a serious injury.The end user reports using nystatin powder, protective barrier wipe and stomahesive powder.No add'l pt/event details have been provided to date and a return sample is not expected.Should add'l info become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY, 78
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: mathew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4072572
• MDR Text Key: 4855511
• Report Number: 9618003-2014-00080
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 020922
• Device Catalogue Number: 020922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention