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

Model Number 175791

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

Patient Problems Rash (2033); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.(b)(4).Note: there are three (3) cases associated with this complaint.A separate 3500a form has been completed for the other two (2) cases.

Event Description

End user reports a fungal rash 360 degrees around the stoma which is causing a decrease in wear time in 5 out of 5 one piece appliances.End user states this began approximately 2 weeks ago.End user reports he has been to his physician who prescribed nystatin anti-fungal powder, however the end user has not used the product.

Manufacturer Narrative

Additional information received november 10, 2015.The product associated with batch 3j00257 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation, is applicable to this complaint investigation.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Additional information: previous applicable nc investigation has been completed.The investigation revealed that the complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user as a result of skin complications 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.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® CONVEX ONE-PIECE UROSTOMY POUCH
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC GLOBAL QARAC HEAD QUARTERS; 7900 triad center drive; suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5192824
• MDR Text Key: 30012289
• Report Number: 1049092-2015-00631
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2018
• Device Model Number: 175791
• Device Lot Number: 3J00257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• 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
• Patient Age: 89 YR
• Patient Weight: 79