MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DR. BROOKS EYE PACK

Catalog Number	LYN006EYDBJ
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "within the pack 3 issues: surgeon gloves breaking as he puts on, cuffs on the gown too tight now, and gowns, the string that goes into the card is much looser than before and can fall too easily.".
Additional Manufacturer Narrative
The account reported finding various issues, including surgeon gloves breaking as he puts on, gown cuffs too tight, and the gown string that goes into the card much looser than before and can fall too easily.No sample or photo was received for the investigation; the finished good production records were reviewed with no line-down situations, no runs without approvals, deviations, or non-conformance reports, and the finished good pack build was reviewed for placement with nothing found to have contributed to the reported issue.The reported problem could not be confirmed because, without a physical sample or photo, the root cause for the glove issue and tight cuffs on the gowns could not be determined.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: DR. BROOKS EYE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754787
• Report Number: 1417592-2026-39289
• Device Sequence Number: 18482005
• Product Code: OJK
• UDI-Device Identifier: 40195327349524
• UDI-Public: 40195327349524
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/10/2026

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: LYN006EYDBJ
• Device Lot Number: 24FBQ284
• Was Device Available for Evaluation?: No
• 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: 11/22/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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