MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HEMO-FORCE; GARMENT,DVT,INT,GEN2,CALF,MEDIUM

Catalog Number	MDS601M2
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer has reported some skin pressure issues since they converted to our # mds601m2bl.
Additional Manufacturer Narrative
Customer has reported some skin pressure issues since they converted to our # mds601m2bl.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.

• Brand Name: HEMO-FORCE
• Common Device Name: GARMENT,DVT,INT,GEN2,CALF,MEDIUM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24743807
• Report Number: 1417592-2026-00293
• Device Sequence Number: 9376653
• Product Code: JOW
• UDI-Device Identifier: 10888277348134
• UDI-Public: 10888277348134
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K170415
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: MDS601M2
• Device Lot Number: 65124100010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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