MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE® ONE-PIECE DRAINABLE CUT-TO-FIT POUCH WITH STOMAHESIVE® SKIN BARRIER; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

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.Patient height: 63 inches.Reported to the fda on october 14, 2015 (b)(4).

Event Description

It was reported the end user developed "pimples" on the skin immediately surrounding the stoma and under the skin barrier after three days of wear.The end user was seen by local wound ostomy continence nurse who applied prescription silver nitrate to the affected area.The end user was advised to try a new skin barrier.No further patient complications were reported.

• Brand Name: ACTIVELIFE® ONE-PIECE DRAINABLE CUT-TO-FIT POUCH WITH STOMAHESIVE® SKIN BARRIER
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; lot 30 - piisa industrial park; carretera sanchez km. 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5151193
• MDR Text Key: 28305225
• Report Number: 9618003-2015-00057
• 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
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 87