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

Model Number 416744

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

Patient Problem Erythema (1840)

Event Date 01/01/2014

Event Type  Injury  

Event Description

It was reported that for approximately eight months the end user had redness under the tape collar and non-blanchable redness to her peristomal skin.It was stated that a prescribed kenalog spray has been used for months but, without improvement.It was recommend the end user try a skin barrier under the tape collar.

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).(b)(6).

• Brand Name: ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4736139
• MDR Text Key: 19648365
• Report Number: 1049092-2015-00229
• 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: 04/17/2015

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: Health Professional
• Device Model Number: 416744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2015
• 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: ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 86