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

Model Number	UNKNOWN SCD DURABLES
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports: we recently had an incident where it was reported by the patient that the device wasn¿t working and did not inflate.The patient ended up with a pulmonary embolism (p.E.) unfortunately.The device's serial number wasn¿t taken as it wasn¿t reported at the time of the event.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned because they did not isolate the controller.
Additional Manufacturer Narrative
Updates were made to the following sections after additional information was provided on 03/03/2025: section a2: age at the time of event.Section a3: gender.Section b7: other relevant history, including preexisting medical conditions.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Additional Manufacturer Narrative
The incorrect sku number was initially reported as 295250 however, the sku was unknown therefore the following fields have been updated: d4: model number - was 295250, updated to unknown scd durables.D4: catalog number - was 295250, updated to unknown scd durables.

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH, INC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21463710
• Report Number: 1423537-2025-00099
• Device Sequence Number: 8822173
• Product Code: JOW
• UDI-Device Identifier: 10192253023015
• UDI-Public: 10192253023015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: UNKNOWN SCD DURABLES
• Device Catalogue Number: UNKNOWN SCD DURABLES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/02/2025; 04/30/2025
• 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: Other
• Patient Age: 37 YR
• Patient Sex: Female