MAUDE Adverse Event Report: CONVATEC INC. EAKIN COHESIVE® SEALS; PROTECTOR, OSTOMY

Model Number 839002

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

Event date: 2015.Based on the available information, this event is deemed to be a serious injury.A previous investigation is applicable to this complaint.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is 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.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

End user reports peristomal skin is red with small multiple areas of open and weepy skin measuring approximately 13mm from stoma outward at 3'0 clock.End user reports first noting this several months ago.End user saw a dermatologist who prescribed fluticasone propionate cream topically for the peristomal skin with little improvement noted.

• Brand Name: EAKIN COHESIVE® SEALS
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5405501
• MDR Text Key: 37335854
• Report Number: 1049092-2016-00030
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 839002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• 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 Age: 76 YR