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

Model Number	83022
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's assessment identified large amount of bruising to bilateral legs in outline of scd [sequential compression device] sleeves.

• 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: 24997927
• Report Number: 24997927
• Device Sequence Number: 21090936
• Product Code: JOW
• UDI-Device Identifier: 10885380186462
• UDI-Public: (01)10885380186462(17)300131(10)50370S02D
• 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): 04/17/2026
• Report Date (Section F): 04/20/2026

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: 04/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 156 KG
• Date Report Sent to FDA: 04/20/2026