MAUDE Adverse Event Report: CONVATEC EAKIN; PROTECTOR, OSTOMY

Model Number	839002
Medical Device Problem Codes	Melted (1385); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user mentioned that she had been using company's stoma seal since 2016.She usually gets seven days wear time.However, with the last two boxes, she had noticed that the ring was melted and got over the stoma within one day of use.At that point, she had to pick off the wax that was covering the opening in the stoma (os).Furthermore, the end user stated that when the wax was covering the opening in the stoma (os) she got liquid stool, and once the wax was removed from the opening in the stoma (os), the stool was darker in color when it came out.Since she had manually removed the wax, the stool was then back to its normal color and was toothpaste in consistency and that it felt well.She was now pushing on the ring with the appliance on, to ensure it was not covering the opening in the stoma (os).Her stoma was protruding well, and she was using another company's two-piece convex appliance with the company's ring.A personal support worker (psw) came weekly to assist with her changes.No photo is available at this time.
Additional Manufacturer Narrative
Device 7 of 13.The end user made no mention of having any type of blockage.Hence, a1409 has not been selected in this emdr.Based on the available information, this event is deemed to be a reportable malfunction.Other company's product name: hollister 2 pcs convex.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Third party manufacturing site: 9681410.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information: this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary: type of investigation: 4109, 3331.Investigation findings: 213, investigation conclusions: 4315.Supplier investigation, received, and the investigation found no faults in the production records and did not identify new defects.No samples were returned for testing, and no abnormalities were recorded in manufacturing paperwork.Previous complaints for this lot number reported similar issues with rings melting or being thinner and harder.The clinical team noted that a stoma appliance should not affect stool consistency and suggested other potential causes, such as digestive issues.The complaint did not meet regulatory reporting criteria, and corrective or preventive actions were deemed unnecessary.However, 13 adverse event reports were submitted to the food and drug administration (fda).This investigation will be closed.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).Fda registration number, reporting site: 1049092, third party manufacturing site: 9681410.

• Brand Name: EAKIN
• Common Device Name: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• MDR Report Key: 21190542
• Report Number: 1049092-2025-00018
• Device Sequence Number: 8603774
• Product Code: FON
• UDI-Device Identifier: 00768455108732
• UDI-Public: 00768455108732
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024
• Report Date (Section F): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 839002
• Device Lot Number: 109357C814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2024
• Date Report to Manufacturer: 01/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 06/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female