MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GARMENT,DVT,INT,GEN1,CALF,MEDIUM

Catalog Number	MDS601MD
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sequential compression device (scd) sleeves were often alarming and the issue would resolve upon changing the product (the scd sleeve), and upon review it was found that the item was defective and not providing an adequate seal.
Additional Manufacturer Narrative
The customer reported that sequential compression device (scd) sleeves were often alarming and the issue would resolve upon changing the product, and that the item was defective and not providing an adequate seal; this did not cause harm to any patient.One pair of dvt sleeves was received, and inadequate sealing was identified near the top of the inner air bladder on one of the sleeves; the opening measured approximately 1¿1.5 inches.Based on the information provided, medline was able to confirm the reported issue and that the product failed to meet specifications.The vendor determined that the root cause of the reported issue is the lack of standardized restart controls for cold-mold operating conditions in the production process.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GARMENT,DVT,INT,GEN1,CALF,MEDIUM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932085
• Report Number: 1417592-2026-53025
• Device Sequence Number: 9589126
• Product Code: JOW
• UDI-Device Identifier: 10080196561513
• UDI-Public: 10080196561513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/26/2026

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
• Device Catalogue Number: MDS601MD
• Device Lot Number: 40125080001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown