MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP RESTORE SENSE; DBD-GLOVE,EXAM,NITRILE,RESTORE,OAT SENSE

Catalog Number	OAT2586
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, they developed a "rash on both hands after consistent use" of the gloves.The customer reported the rash developed after "1.5 months" of using the product, and the rash "resembles contact dermatitis, itchy, red".The customer reported that prior to identifying the cause of the rash he was prescribed "triamcinolone 0.1%", but the issue did not resolve despite the ointment application until he discontinued using the gloves.The customer did not report any serious injury related to the reported incident.No additional details are available related to the customer reported issue.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.
Event or Problem Description
According to the customer, they developed a "rash on both hands after consistent use" of the gloves.

• Brand Name: RESTORE SENSE
• Common Device Name: DBD-GLOVE,EXAM,NITRILE,RESTORE,OAT SENSE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23822613
• Report Number: 1417592-2025-00718
• Device Sequence Number: 9332071
• Product Code: LZA
• UDI-Device Identifier: 10888277629615
• UDI-Public: 10888277629615
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162819
• 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): 12/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: OAT2586
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/16/2025
• 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: 26 YR
• Patient Sex: Male
• Patient Weight: 82 KG