MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; MAJOR LAP

Catalog Number	DYNJ82798A
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Linting from blue or towels.
Additional Manufacturer Narrative
It was reported that the linting from blue or towels.There were no reports of death, serious injury, medical intervention, or follow up care.

• Brand Name: MEDLINE
• Common Device Name: MAJOR LAP
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; parque industrial del desierto; baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25053538
• Report Number: 1423395-2026-00117
• Device Sequence Number: 18466624
• Product Code: FDE
• UDI-Device Identifier: 10198459285264
• UDI-Public: 10198459285264
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: Health Professional
• Device Catalogue Number: DYNJ82798A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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
• Patient Sex: Unknown