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

Catalog Number	NON27385
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility contact "starting in the middle of january," "we have had employee complaining about the surgical mask breaking their face out with hot bright red rash." per the facility contact, "employee's eyes and face swelled, neck had blistering and rash where mask sat around neck" and "face had blistering and rash where mask was in contact with skin." the facility contact stated, the "employee went to urgent care" and "received steroids to help with reaction to masks." the facility contact reported, "the employee is better when not in contact with masks, another brand is being used." no additional information is available at this time regarding the customer reported incident.A sample has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility contact "starting in the middle of january," "we have had employee complaining about the surgical mask breaking their face out with hot bright red rash.".

• Brand Name: MEDLINE FACE MASK
• Common Device Name: MASK, TIE, WHITE, HYPOALLERGENIC, LVL 1
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24718650
• Report Number: 1417592-2026-00291
• Device Sequence Number: 5777522
• Product Code: FXX
• UDI-Device Identifier: 10080196713974
• UDI-Public: 10080196713974
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223236
• 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): 03/27/2026

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: NON27385
• Device Lot Number: 85825084279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 200 LB
• Patient Race: White