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

Model Number	83022
Health Effect - Clinical Codes	Itching Sensation (1943); Hot Flashes/Flushes (2153); Discomfort (2330); Diaphoresis (2452)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient refused to wear sequential compression device (scd) leg sleeves due to them being scratchy, hot/sweaty and uncomfortable.Nurse removed the scd leg sleeves and educated patient to ambulate with staff throughout the day for blood clot prevention.

• 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: 24965341
• Report Number: 24965341
• Device Sequence Number: 10463992
• 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
• Was Device Available for Evaluation?: Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 04/14/2026