MAUDE Adverse Event Report: CONVATEC INC. EAKIN COHESIVE® SEALS, SMALL 2",(48MM) (1X20PK); PROTECTOR, OSTOMY

Model Number 839002

Device Problems Degraded (1153); Difficult to Remove (1528)

Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the end user's peristomal skin is red and itchy with small blisters under the mass.She reported that the eakin seal became "partially liquified" and she had to "pick off the eakin seal in small pieces." the end user reported that the reason she developed the reported skin irritation was due to the product.

Manufacturer Narrative

The original equipment manufacturer (oem) performed a batch record review for lot# 1093578477 and no discrepancies were indicated.This issue will be monitored through the post market product monitoring review process.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: EAKIN COHESIVE® SEALS, SMALL 2",(48MM) (1X20PK)
• 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: 5661003
• MDR Text Key: 45368658
• Report Number: 1049092-2016-00225
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Model Number: 839002
• Device Lot Number: 1093578477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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