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

Catalog Number	MDS601MSQ
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Discoloration (2074)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2026 the "rn noted bruising and discoloration to patient's calf under scd sleeve." per the facility, "right lower extremity with scattered areas of linear maroon and dark purple discoloration, mainly on posterior, medial, and lateral sides.Skin is intact.Likely due to pressure from scds." following discovery of the "deep tissue injury" scd use was discontinued and "sween24 lotion" was applied to the lower extremity.Per the facility, the individual has since passed away unrelated to the reported device complaint.No additional information is available at this time.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, on (b)(6) 2026 the "rn noted bruising and discoloration to patient's calf under scd sleeve." per the facility, "right lower extremity with scattered areas of linear maroon and dark purple discoloration, mainly on posterior, medial, and lateral sides.Skin is intact.Likely due to pressure from scds." following discovery of the "deep tissue injury" scd use was discontinued and "sween24 lotion" was applied to the lower extremity.Per the facility, the individual has since passed away unrelated to the reported device complaint.

• Brand Name: HEMO-FORCE SQ
• Common Device Name: GARMENT,DVT,SEQUENTIAL,CALF,MEDIUM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25191800
• Report Number: 1417592-2026-01389
• Device Sequence Number: 21441050
• Product Code: JOW
• UDI-Device Identifier: 10884389145708
• UDI-Public: 10884389145708
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MDS601MSQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 93 KG