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

Model Number 125353

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

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Ulcer (2274); Fluid Discharge (2686)

Event Date 02/01/2014

Event Type  Injury  

Event Description

The end user reported that approximately one year ago, she was admitted to a skilled nursing facility following a motor vehicle accident.During her stay at the facility, the nursing staff would cut the pre-put ostomy pouch prior to application.Shortly after, she developed a superficial wound near the stoma.The would has progressed since that time and now measures thirty-eight mm (round) and six mm (depth).The end user described the wound bed as dark red and moist and continually increasing in size.The edges bleed easily with cleaning, but the end user is reportedly able to control the bleeding quickly with pressure.The skin surrounding the wound has a purple discoloration and is tender.In addition, the wound has an undetermined amount of clear drainage which led to barrier erosion and, subsequently, daily pouch changes.The end user consulted a local wound ostomy nurse on several occasions and was advised to use the crusting technique to the application site.The end user has attempted crusting the area without much success.The pt consulted a colorectal surgeon on (b)(6) 2014.The surgeon reportedly cauterized the wound with silver nitrate.The pt was advised to use a dressing over the wound prior to pouch application.In addition, the end user was urged to follow up with her colorectal surgeon or dermatologist for add'l diagnostics and treatment.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.Not add'l pt/event details have been provided to date.Should add'l info become available, a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 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, interm assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4534273
• MDR Text Key: 20772234
• Report Number: 1049092-2015-00109
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2015
• 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: MAGNESIUM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR