MAUDE Adverse Event Report: CONVATEC INC. ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 413515

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

(b)(6) based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on april 6, 2016.(b)(4).

Event Description

End user reports rash to skin under the entire wafer.According to the end user, the skin issues resolve when using non-adherent product but, returns when using adhesive.She was prescribed triamcinolone cream by a physician.

Manufacturer Narrative

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: ESTEEM® + MOLDABLE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5552236
• MDR Text Key: 42011870
• Report Number: 9618003-2016-00015
• Device Sequence Number: 1
• Product Code: EZQ
• 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
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66