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

Model Number	74022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Inflammation/ Irritation (4545)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that alcare stockings and scd700 comfort sleeves were attached to the patient who was transported by emergency ambulance due to heat stroke on 06/03 and on 06/05 fist-sized skin tissue trouble (inflammation of the skin) was confirmed on the lower limbs/calf.The symptoms were confirmed as low temperature burns.Worsening/deterioration of the affected area was seen and hospitalization was extended.Photos of the affected area were requested but are not available.The product was discarded at the hospital and no further information is available.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by 1uality, prior to the release of product.A sample was not received for the investigation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate the sample as part of a comprehensive failure investigation.According to the event description, the sleeve was used along with alcare stockings which are not manufactured by cardinal health.The customer did not provide any further information related to the compression provided by the alcare stockings or the configurate pressure set on the air pump.Since the instructions for the correct sleeve use mentions; ¿to ensure the product safety and efficacy, all compression systems kendall scd must only be used with kendall scd sleeves¿ and according to the event, the compression system kendall scd was used with the sleeve and the alcare stockings, it can be concluded that the customer did not adequately follow the instructions for use since kendall scd compression system must only be worn with the kendall scd sleeve.Based on all available information, the most probable root cause of the condition reported could be related to the stockings used during the patient¿s treatment.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD COMFORT KNEE LENGTH MED
• 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: 14790864
• Report Number: 3009211636-2022-00790
• Device Sequence Number: 5936231
• Product Code: JOW
• UDI-Device Identifier: 10192253016154
• UDI-Public: 10192253016154
• 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): 07/28/2022

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: 74022
• Device Catalogue Number: 74022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/28/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown