MAUDE Adverse Event Report: CONVATEC EAKIN; BAG, DRAINAGE, WITH ADHESIVE, OSTOMY

Model Number	839002
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdevice 2 of 3.A default value was selected as the weight, as it was a requirement for submission.The actual weight is unknown.Based on the available information, this event is deemed to be a reportable malfunction.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
The nurse reported that seals were dried out and crumbled before use.Consumer had used previously (for several years).Tried three wafers so far from the box.No photo was available at this time.

• Brand Name: EAKIN
• Common Device Name: BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• MDR Report Key: 25608144
• Report Number: 1049092-2026-00182
• Device Sequence Number: 5520931
• Product Code: FON
• UDI-Device Identifier: 00768455108732
• UDI-Public: 00768455108732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/29/2026
• Report Date (Section F): 06/04/2026

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: Health Professional
• Device Model Number: 839002
• Device Lot Number: 109357D450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2026
• Date Report to Manufacturer: 06/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female