MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP OPTIVIEW; OPTIVIEW, MULTISITE, 3"X3"

Catalog Number	MSCOVM3EP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Contact Dermatitis (4546); Swelling/ Edema (4577)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, after applying the dressing for "24 hours" they developed "itching, swelling, and hives to the area of the gel center".
Additional Manufacturer Narrative
According to the customer, after applying the dressing for "24 hours" they developed "itching, swelling, and hives to the area of the gel center".The customer reported that after the incident occurred, they were "placed on 2.5 weeks of corticosteroids" to treat their "contact dermatitis".The customer did not report any serious injury related to the reported incident.No additional information is available at this time.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: OPTIVIEW
• Common Device Name: OPTIVIEW, MULTISITE, 3"X3"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24874014
• Report Number: 1417592-2026-00438
• Device Sequence Number: 10028778
• Product Code: NAD
• UDI-Device Identifier: 10197344155620
• UDI-Public: 10197344155620
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/14/2026

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 Catalogue Number: MSCOVM3EP
• Device Lot Number: NV24525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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 Sex: Female