MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC UROSTOMY POUCH W/DURAHESIVE; 78 EXH

Model Number 650833

Device Problem Increased Sensitivity (2535)

Patient Problems Inflammation (1932); Rash (2033); Burning Sensation (2146)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It is reported that end-user developed a rash around last summer.The rash was described as red with blisters and burning.The end-user stated that the physician thought it was fungal and prescribed fluconazole (diflucan) orally for fourteen (14) days with no improvement.It is reported that the product has been in use for many years and developed rash last summer.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury since the patient did seek medical treatment and received a prescription.It is reported that end-user cleanses skin with allkare adhesive remover wipes then washes with dial soap and water then dries.In addition, end-user applies allkare protective barrier wipes and allows to dry.Lastly, it is reported that end-user occasionally uses adept powder.Please not: this case is related to patient identifier#: (b)(6), reported under manufacturer's report#: 1049092-2014-00148.No additional patient/even details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

Manufacturer Narrative

The product associated with batch 2l01956 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE 1 PC UROSTOMY POUCH W/DURAHESIVE
• Type of Device: 78 EXH
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 3862764
• MDR Text Key: 21496252
• Report Number: 1049092-2014-00149
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/20/2017
• Device Model Number: 650833
• Device Catalogue Number: 650833
• Device Lot Number: 2L01956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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