MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LASIK HACKENSACK MED CTR

Catalog Number	VAL011LSHAC
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 kits were used minus the defective items (tegaderms) that were unable to be used.
Additional Manufacturer Narrative
The account reported finding adhesive issue dressing, and the complaint transcript noted defective items (tegaderms) that were unable to be used.No sample or photo was received for the investigation; the pack production record was reviewed and there were no line-down situations, runs without approvals, deviations, or non-conformance reports that might have had an impact on this issue, and the pack component locations were reviewed and the location of the dressing likely did not contribute to the reported issue.The reported issue could not be confirmed without a sample, and without a physical sample or photo, the root cause could not be determined at this time.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-LASIK HACKENSACK MED CTR
• 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: 50519091
• Report Number: 1417592-2026-27862
• Device Sequence Number: 13105334
• Product Code: OJK
• UDI-Device Identifier: 40193489413039
• UDI-Public: 40193489413039
• 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): 08/29/2026

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: VAL011LSHAC
• Device Lot Number: 23KBA525
• 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: 04/03/2024
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown