BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCD COMFORT KNEE LENGTH MED

    MDR report key: 14790864 · Received June 23, 2022

    Report

    Report Number
    3009211636-2022-00790
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    June 5, 2022
    Report Date
    July 28, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JOW
    UDI-DI
    10192253016154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307949 SCD COMFORT KNEE LENGTH MED SLEEVE, LIMB, COMPRESSIBLE JOW CARDINAL HEALTH 74022 10192253016154

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization