MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-EYE PK EYE LASER INSTITU

Catalog Number	VAL022EPLIC
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	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 3m drapes in the val022eplic was not sticking to the patient's face.
Additional Manufacturer Narrative
The account reported finding an adhesive issue with the drapes; patient contact was reported, and patient was not harmed or injured, with no patient infections or injury noted and it would just come unstuck.A sample of a used drape was received for investigation, finished good production records were reviewed, the finished good pack build was reviewed, and trending was reviewed.With the received sample medline was able to confirm the issue; the sample was sticking to itself and appeared to have been used, and there was no other physical damage.Medline was unable to determine the root cause with the received sample; this complaint was provided to the vendor for further evaluation, no response was received from the vendor after two follow ups, and the supplier quality team will monitor this issue for trending purposes.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 PK EYE LASER INSTITU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753245
• Report Number: 1417592-2026-39055
• Device Sequence Number: 9195219
• Product Code: OJK
• UDI-Device Identifier: 40889942339380
• UDI-Public: 40889942339380
• 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): 09/14/2026

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: VAL022EPLIC
• Device Lot Number: 22JBD317
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2023
• 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: 03/07/2023
• Initial Report FDA Received Date: 09/14/2026
• 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