MAUDE Adverse Event Report: MEDLINE RENEWAL HEMO-FORCE; MDS601MSQ HEMO-FORCE SEQNTL SLEEVE-BLND

Catalog Number	MDS601MSQBL
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on 5/5/2026, cvicu nurse manager (b)(6), rn at (b)(6) hospital reported that they have a patient who was wearing our medium sequential dvt sleeve and experienced dti.Wounds appeared on the lower legs and the sleeve was removed.I met with the reporting nurse, and the interpretation is the patient had wounds already on the legs however the tubing may have contributed to it because of the sleeve placement.
Additional Manufacturer Narrative
According to the facility, on 5/5/2026, cvicu nurse manager (b)(6), rn at (b)(6) hospital reported that they have a patient who was wearing our medium sequential dvt sleeve and experienced dti.Wounds appeared on the lower legs and the sleeve was removed.I met with the reporting nurse, and the interpretation is the patient had wounds already on the legs however the tubing may have contributed to it because of the sleeve placement.There was no additional follow-up needed.No additional information at this time.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: HEMO-FORCE
• Common Device Name: MDS601MSQ HEMO-FORCE SEQNTL SLEEVE-BLND
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25363082
• Report Number: 3032391-2026-00024
• Device Sequence Number: 13444166
• Product Code: JOW
• UDI-Device Identifier: 10884389145708
• UDI-Public: 10884389145708
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MDS601MSQBL
• Device Lot Number: 40125100003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male