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 Codes	Nerve Damage (1979); Hypoesthesia (2352)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
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 for evaluation but did not provide rationale.
Event or Problem Description
Customer reports that the use of the scd comfort sleeve caused peroneal nerve palsy.On tuesday, (b)(6), she underwent spine surgery at the orthopedic department and returned to the ward.Decreased manual muscle strength measurement (mmt) and hypoesthesia upon returning to the room.Perhaps because the wound is painful, painkillers are used in the operating room.After 3 hours, strong complaints of hypesthesia.The doctor's report was that the patient was diagnosed with peroneal nerve palsy.A plantar sleeve is used during surgery, and a sleeve below the knee is used after surgery.The foot pump was turned on and started after observation of vital signs and the like.At the 3 hour time of observation, there was mmt, sensory confirmation, and pain, and since block injections were not given, pain relief was performed.Four hours later, it was reported to the doctor, and during the examination, he pointed out that the lower limb sleeve was compressing the fibula head and he noticed that compression it was from the lower limb sleeve of the foot pump.The cause was determined to be "inappropriate use of a foot pump to prevent venous embolism".As a countermeasure, the public was informed about the size of the lower limb sleeve.Size checking in the operating room is routinely carried out, but after returning to the ward, the size selection was added again.The patient was 85 years old (female), height 147.0 cm, weight 47.5 kg, lower limb sleeve was compressing the fibula head, so it was used in a smaller size.The length of the m/l is the same, so it was changed it to a size s.The period of use of the medical device was 4 hours from the start of the foot pump.
Additional Manufacturer Narrative
Based on information reviewed, it has been determined that no manufacturing related issue was found.The manufacturing facility has controls in place for the scd sleeves, and the instructions for use (ifu) contains precaution instructions which states 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." in addition, although a sample nor lot number was provided, based on the customer's description ¿during the examination, the doctor pointed out that the lower limb sleeve was compressing the fibula head and he noticed that the compression was from the lower limb sleeve of the foot pump.The cause was determined to be "inappropriate use of a foot pump to prevent venous embolism.".

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan OH 60085
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20678414
• Report Number: 1423537-2024-00304
• Device Sequence Number: 15529833
• Product Code: JOW
• UDI-Device Identifier: 10192253016147
• UDI-Public: 10192253016147
• 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
• Report Date (Section B): 01/02/2025

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
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/02/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 47 KG