MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; OPTICLOSE ESSENTIAL ADHESIVE, 0.55ML

Catalog Number	MSC091040H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) in an or surgery, the product was being used when being applied to a surgical closure in the or.The patient experienced a rash as a reaction.
Additional Manufacturer Narrative
According to the facility on (b)(6) in an or surgery, the product was being used when being applied to a surgical closure in the or.The patient experienced a rash as a reaction.After the issue was noted, antibiotics were needed.The patient seems to be recovering with antibiotics.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.

• Common Device Name: OPTICLOSE ESSENTIAL ADHESIVE, 0.55ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21731520
• Report Number: 1417592-2025-00149
• Device Sequence Number: 4147829
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/28/2025
• Device Catalogue Number: MSC091040H
• Device Lot Number: P00231136
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 78 KG