MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MASK, TIE, WHITE, HYPOALLERGENIC, LVL 1

Catalog Number	NON27385
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the product is causing "allergic reactions so badly we are having to give benadryl injections." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event caused or contributed to serious injury, therefore, 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, the product is causing "allergic reactions so badly we are having to give benadryl injections.".

• Common Device Name: MASK, TIE, WHITE, HYPOALLERGENIC, LVL 1
• 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: 21154228
• Report Number: 1417592-2025-00030
• Device Sequence Number: 9189613
• Product Code: FXX
• UDI-Device Identifier: 40080196713975
• UDI-Public: 40080196713975
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: NON27385
• Device Lot Number: 85824067171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/14/2025
• 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 Sex: Unknown