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

Model Number	839005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); 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 end user reported that company's cohesive seals were less pliable, firmer and less adhesive and more difficult for her to mold into place.She stated that the adhesive on them felt spotty.Furthermore, she mentioned that four out of two market units had the same lot number, that she used two seals at a time and tried two from each box and both felt the same.She referred that she had been using this product for over ten years and had never had a problem.She denied any changes to other accessory products or her pouching system.The user reported that she wore another brand pouch and stated that her normal wear time was four to five days, but with this shipment of our company's seals, her wear time had decreased to every two days.She stated that she did not want to use any more seals from these boxes.No photo was available at that time.
Additional Manufacturer Narrative
Mdr 1049092-2026-00206 - device 1 of 4.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.

• 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: 50252161
• Report Number: 50252161
• Device Sequence Number: 13275895
• 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: 109357D438
• 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: 08/14/2026
• 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