MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE CONVEX ONE-PIECE UROSTOMY POUCH WI; BAG, URINARY, ILEOSTOMY

Model Number 175795

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

Patient Problem Erythema (1840)

Event Date 08/01/2014

Event Type  Injury  

Event Description

It was reported that an end user developed redness under the tape collar and mass of the skin barrier.The redness stops approximately 7 millimeters from the end user's stoma and is noticeably worse under the white tape collar.Over a period of a few months, the end user attempted to treat the area with over the counter benadryl cream and spray, his physician also prescribed cortisone cream, silvadene cream and bactrim and he has used various products from various manufacturers; however the redness has persisted.The end user has noted some improvement when he applies a hydrocolloid dressing prior to applying the skin barrier.In addition, the end user can tolerate wearing the skin barrier for longer (3 days) when the dressing is applied than when no dressing is applied (1 day).The end user is being monitored by a nurse at his local wound clinic and is not being treated with medications at this time.

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.

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE UROSTOMY POUCH WI
• Type of Device: BAG, URINARY, ILEOSTOMY
• 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: 4647873
• MDR Text Key: 5610944
• Report Number: 1049092-2015-00179
• Device Sequence Number: 1
• Product Code: EXH
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2015
• 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
• Treatment: CURRENT MEDICATIONS: BLOOD PRESSURE; NAUSEA MEDICATION (NAMES/DOSAGES NOT PROVIDED).
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73