MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; MASK, LOOP, BLUE, LVL 1

Catalog Number	NON27378
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per email, customer explained that one ear loop would snap when putting on.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
Per email, customer explained that one ear loop would snap when putting on.

• Brand Name: MEDLINE
• Common Device Name: MASK, LOOP, BLUE, LVL 1
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25118731
• Report Number: 1417592-2026-01027
• Device Sequence Number: 10354537
• Product Code: FXX
• UDI-Device Identifier: 10080196717996
• UDI-Public: 10080196717996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NON27378
• Device Lot Number: 6642509001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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
• Patient Sex: Unknown