BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWTRON/UNIVERSAL PUMPS

    MDR report key: 2894403 · Received November 30, 2012

    Report

    Report Number
    3005619970-2012-00012
    Event Type
    Other
    Date Received
    November 30, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION ((B)(4)) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR (GETINGE (B)(4) CO., LTD.).(B)(4). ADD'L INFO WILL BE PROVIDED UPON THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6), AE WAS INFORMED BY A FACILITY WCN THAT PT DEVELOPED BRUISING WHILE USING THE FLOWTRON GARMENTS (THIGH GARMENTS). MESSAGE LEFT FOR WCN ON (B)(6) 2012 TO GATHER ADD'L DETAILS. AE MET WITH WCN IN PERSON ON (B)(4). WCN FEELS THIS IS MOST LIKELY A STAFF ISSUE AT THIS POINT. AC600 PUMP NOT ISOLATED. WILL ATTEMPT TO CONTACT WCN AGAIN FOR FURTHER DETAILS. PT DEVELOPED UNSTAGEABLE BILATERAL LOWER LEG PRESSURE ULCERS ON LATERAL ASPECTS OF LEGS, THAT EXTENDED INTO STAGE 3 AND STAGE 4 PRESSURE ULCERS (12 CM X 2-3CM WITH TENDON EXPOSED); IPC WAS DISCONTINUED. PT HAS NUMEROUS COMORBIDITIES AND SUBSEQUENTLY EXPIRED; WCN STATED THAT THE PT'S DEATH UNRELATED TO PRESSURE ULCER DEVELOPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON/UNIVERSAL PUMPS JOW GETINGE (SUZHOU) CO. LTD. 507003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other