MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; SLEEVE, LIMB, COMPRESSIBLE

Model Number	83022
Health Effect - Clinical Codes	Diaphoresis (2452); Skin Inflammation/ Irritation (4545)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient refused to wear sequential compression device (scd) leg sleeves because it makes him sweat and causes irritation on shins and calves.

• Brand Name: KENDALL
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 24965304
• Report Number: 24965304
• Device Sequence Number: 13353054
• Product Code: JOW
• UDI-Device Identifier: 10885380186462
• UDI-Public: (01)10885380186462
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2026
• Report Date (Section F): 04/14/2026

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 Model Number: 83022
• Device Catalogue Number: 83022
• Device Lot Number: 50370S02D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Date Report Sent to FDA: 04/14/2026