MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EYE PACK

Catalog Number	DYNJ69598A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when they pull the border piece to get the backing off, the clear sticky part stays on the backing.Then the clear part starts rolling up and sticking to itself making it unusable.".
Additional Manufacturer Narrative
The account reported finding adhesive issue with sure site.A sample was received for the investigation; the account returned 5 dressings, all the dressings provided had been peeled, and the liner was partially or completely removed from the dressings with the film stuck to the backing.All samples confirm the issue reported by the account.The root cause is considered to be a vendor product issue relating to the component manufacturing process; the issue derives from the raw materials process when the force between frame liner and the film is too weak, and the complaint has been provided to the component manufacturing facility for further evaluation.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-EYE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50816764
• Report Number: 1417592-2026-44485
• Device Sequence Number: 10680282
• Product Code: OJK
• UDI-Device Identifier: 40195327363520
• UDI-Public: 40195327363520
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Device Catalogue Number: DYNJ69598A
• Device Lot Number: 23LMG409
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown