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

Model Number 416751

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

Patient Problem Skin Irritation (2076)

Event Date 10/23/2014

Event Type  Injury  

Event Description

End user reported redness to peristomal skin under tape collar of product.She reports the redness started within one hour of wearing the product.She called her primary physician, who prescribed oral diflucan and unknown brand of hydrocortisone cream.No reaction or yeast was diagnosed the redness improved after cutting away tape border.She has temporarily gone back to an alternate product.

Manufacturer Narrative

Based on the available information, the 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.

• 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 ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4289283
• MDR Text Key: 20015384
• Report Number: 1049092-2014-00592
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• 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: FENTANYL PATH FOR RECENT TWO AMPUTATION; VANCOMYCIN
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 73