MAUDE Adverse Event Report: CARDINAL HEALTH SCD COMFORT KNEE LENGTH SM; SLEEVE, LIMB, COMPRESSIBLE

Model Number	74021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/30/2023
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
The customer reported that a blood clot occurred to a patient who wore a small-size comfort sleeve.The patient's right upper calf got swollen, and the patient was diagnosed with a thrombus.The doctor has pointed out that not enough pressure might have been applied because the size small was somewhat small for the patient's leg.It is reported that the nurse did not put the sleeves on the patient firmly, thus it seems less likely the sleeve was tightening the lower leg.Usage period is 1 day.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because the lot number was not available.However, all dhrs are reviewed to meet regulatory requirements prior to product release.A sample was not returned for evaluation.No additional information, pictures or videos were received.The root cause could not be determined.No actions are required at this time because the issue was not confirmed as manufacturing related.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
A3 patient gender was added additional information: a male patient, born in 1968, was in the lithotomy position.Blood clots occurred on his right soleal vein where a swelling was observed.The patient took lixiana (edoxaban tosilate hydrate).The swelling has gone down, and the patient is in good condition.The patient was wearing the small size of the sleeves, which originally the doctor had thought might be the wrong size, but upon re-examining, small was the right size for the patient.

• Brand Name: SCD COMFORT KNEE LENGTH SM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17305451
• Report Number: 3009211636-2023-00820
• Device Sequence Number: 17738397
• Product Code: JOW
• UDI-Device Identifier: 10884521130852
• UDI-Public: 10884521130852
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 06/30/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/13/2023; 09/01/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male