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

Model Number 125354

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.Additional information was requested.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

End user reports poor wear time with one piece pouches, and that because she cannot keep a pouch on for more than 1 hour, her skin is now reddened with welts on peristomal skin.End user also states there are open areas at 3 o'clock position, in crease by navel and at 6 o'clock position under stoma.End user states in the crease by her navel there are little white bumps as well.End user states she has been using crusting technique with nystatin powder and the sting free barrier wipes.End user is unsure when nystatin powder was prescribed.She is to follow up with her surgeon on (b)(6) 2015.

• Brand Name: ACTIVELIFE® CONVEX ONE-PIECE PRE-CUT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5237493
• MDR Text Key: 31658641
• Report Number: 1049092-2015-00663
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• 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: HYDROCODONE (RPN-AS NEEDED)
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 74