BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON ACS900

    MDR report key: 5821988 · Received July 26, 2016

    Report

    Report Number
    3005619970-2016-00012
    Event Type
    Injury
    Date Received
    July 26, 2016
    Report Date
    June 28, 2016
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT A PATIENT SUSTAINED DVT (DEEP VEIN THROMBOSIS) POST DISCHARGE AFTER USAGE OF ARJOHUNTLEIGH DVT PREVENTION SYSTEM DURING SURGERY. IT WAS REPORTED THAT THE PATIENT INVOLVED HAD NO FORM OF DVT PREVENTION COMPRESSION ON OPERATIVE LIMB OR PHARMA DURING SURGERY (RIGHT ACHILLES TENDON). SURGERY TIME WAS 65 MINUTE, 40 MINUTE TOURNIQUET TIME. GARMENTS WERE OURS, BUT WERE REPROCESSED BY STRYKER (MULTIPLE TIMES). STILL TRYING TO CONFIRM IF THIS IS A HOSPITAL AGREEMENT FOR RE-PROCESSING (AND THEREFORE NOT AHUS LABELING) OR IF IT IS RE-PROCESSED BY OUR SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476388 FLOWTRON ACS900 FLOWTRON ACS900 JOW GETINGE (SUZHOU) CO., LTD. 526000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other