MAUDE Adverse Event Report: CONVATEC, LLC ACTIVELIFE 1 PC UROSTOMY CONVEX POUCH W/DH

Model Number 175794

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

Patient Problems Unspecified Infection (1930); Rash (2033); Urinary Tract Infection (2120)

Event Date 09/23/2014

Event Type  Injury  

Event Description

It was reported by the caregiver that the end user developed a rash on the skin from urine on the skin.Per the caregiver, the device was kept on longer than recommended with the end user developing an infection on the skin.End user was diagnosed by medical doctor with skin infection (under device material) and urinary tract infection and was placed on prescription strength antibiotic cream and oral antibiotics.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Per the information received, the end user ran out of supplies and kept same appliance on longer than recommended.Current skin care consists of cleansing with water then pats dry and applies cream and then applies water.Skin care was discussed with end user.End user will see wound ostomy continence nurse at end of week for re-evaluation but, skin appears to be slightly better since on medication.The medication names were not known by the caregiver.No patient/event details has been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: the date of event was not provided, therefore the date used was the date convatec became aware.

• Brand Name: ACTIVELIFE 1 PC UROSTOMY CONVEX POUCH W/DH
• Manufacturer (Section D): CONVATEC, LLC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4172030
• MDR Text Key: 5100013
• Report Number: 1049092-2014-00521
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175794
• Device Catalogue Number: 175794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 77