MAUDE Adverse Event Report: CONVATEC ACTIVELIFE ONE-PIECE UROSTOMY POUCH WITH DURA; BAG, URINARY, ILEOSTOMY

Model Number 650831

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

Patient Problems Erythema (1840); Rash (2033); Wheal(s) (2241)

Event Date 02/01/2015

Event Type  Injury  

Event Description

The end user reported she developed a red, raised rash under her appliance approximately 1 month ago.She stated she was prescribed triamcinolone ointment, nystatin ointment and a two week course of oral diflucan.The end user further indicated the prescribed ointments are interfering with proper device adhesion.The end user was advised to switch to a powder form of anti-fungal.No further information was provided.

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 ONE-PIECE UROSTOMY POUCH WITH DURA
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int. assoc dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4640933
• MDR Text Key: 5755388
• Report Number: 1049092-2015-00172
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 650831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2015
• 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: MEDICATION: FOR HYPERTENSION (NAME NOT PROVIDED).
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91