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

Model Number	74021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: a hematoma was discovered during the use of scd700, and an incision was required for retrieval.I have been using it since (b)(6) and noticed that a hematoma had formed on the morning of (b)(6).The patient had edema even before using the scd700 system.It is unknown how much edema it was.Currently, the treatment is over and the patient's condition is stable, and scd is not being used.It seems that the alarm does not go off during use, but i asked for an investigation of the main unit and consumables to see if there is a possibility that the pressure has temporarily increased.The usage period was 9 days.
Additional Manufacturer Narrative
Section d4: lot number added after receiving additional information after the initial 3500a was submitted.
Additional Manufacturer Narrative
The device history record review was conducted for lot 2430300319 and there were no issues noted during the manufacturing of this lot.The physical samples were received and evaluated as part of our investigation.The samples met requirements, and we were unable to duplicate the reported event.The ifu contains precaution instructions that the sleeve must be properly placed to avoid potential pressure points and for proper application, two fingers should be able to fit between the sleeve and the leg.The correct fit should be routinely assessed.This potential cause is considered as a probable root cause.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22617878
• Report Number: 1423537-2025-00293
• Device Sequence Number: 19994698
• Product Code: JOW
• UDI-Device Identifier: 10192253016147
• UDI-Public: 10192253016147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2025

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?: No
• Device Model Number: 74021
• Device Catalogue Number: 74021
• Device Lot Number: 2430300319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/05/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown