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

Model Number 175777

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

Patient Problems Skin Inflammation (2443); Blood Loss (2597)

Event Type  Injury  

Event Description

It was reported by a wound ostomy continence nurse that an end user has a small amount of bleeding from the granulomas at the mucocutaneous juncture.The end user was seen by her doctor who applied silver nitrate to the granulomas.It was also reported the end users stoma measures 22mm, but she is using a 19mm stoma opening.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIVE CONVEX ONE-PIECE PRE-CUT DRAINABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4505941
• MDR Text Key: 5528668
• Report Number: 1049092-2015-00095
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR