MAUDE Adverse Event Report: T.G. Eakin Ltd Eakin; Bag, Drainage, With Adhesive, Ostomy

Model Number	839005
Medical Device Problem Codes	Positioning Failure (1158); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The consumer reported that the eakin cohesive seals were less pliable and firmer than expected, making them more difficult to mold into place.She also stated that the adhesive felt spotty.The issue was observed in four units from two market boxes bearing the same lot number.The consumer stated that she used two eakin cohesive seals at a time and had tried two seals from each box.She reported that all the seals felt the same and indicated that she did not wish to use any additional seals from the affected boxes.The consumer had been using the product for over ten years and stated that she had never previously experienced any problems.She denied any changes to her other accessory products or pouching system.She reported using a competitor pouch and stated that her typical wear time was four to five days.However, with the seals from the affected shipment, her wear time had decreased to approximately two days.She attributed the reduced wear time to the seals being less pliable and less adhesive than usual.No photographs are available at this time.
Additional Manufacturer Narrative
Mdr 1049092-2026-00207 / device 1 of 4 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.

• Brand Name: Eakin
• Common Device Name: Bag, Drainage, With Adhesive, Ostomy
• Manufacturer (Section D): T.G. Eakin Ltd; 15 ballystockart rd; comber, country down BT23- 5QY; UK BT23-5QY
• MDR Report Key: 50238935
• Report Number: 50238935
• Device Sequence Number: 18728233
• Product Code: FON
• UDI-Device Identifier: 00768455118250
• UDI-Public: 00768455118250
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 07/22/2026
• Report Date (Section F): 07/22/2026

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: Lay User/Patient
• Device Model Number: 839005
• Device Lot Number: 109357D272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2026
• Date Report to Manufacturer: 07/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female