MAUDE Adverse Event Report: CARDINAL HEALTH KENDALL SCD 700 SEQUENTIAL COMPRESSION SYSTEM; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295257
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) 2025.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
No samples or photos were provided for review, so the complaint could not be confirmed nor a root cause determined.The harm reported within this case is a hematoma which is reflected in the products risk analysis chart as unspecified tissue injury a device malfunction versus misuse of the device cannot be determined as the complaint indicates the patient had edema before using the device but the extent and reason for the edema is unknown.There is insufficient information to determine if any harm occurred as a result of the device.Design quality has conducted a 5-year complaint analysis for scd 700, comfort sleeve knee length size small, and scd express tubing set and there were no other complaints related to a hematoma.Additionally, in the event that the device did have increased pressure, the system is inherently designed to error for high pressure when the leg sleeve pressure is greater than 47 mmhg for 10 consecutive cycles or pressure is above 65 mmhg for 5 consecutive cycles.If this error occurs, the device will stop therapy until the issue is resolved and pressures are back within the appropriate operating range.No new actions will be taken.If additional information is received, this complaint will be reopened.This complaint will be tracked and trended to determine if there is a need for further actions.

• Brand Name: KENDALL SCD 700 SEQUENTIAL COMPRESSION SYSTEM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22615550
• Report Number: 1423537-2025-00291
• Device Sequence Number: 21358853
• Product Code: JOW
• UDI-Device Identifier: 10884521129603
• UDI-Public: 10884521129603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 295257
• Device Catalogue Number: 295257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown