BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWTRON/UNIVERSAL PUMPS

    MDR report key: 2870175 · Received December 10, 2012

    Report

    Report Number
    3005619970-2012-00011
    Event Type
    Other
    Date Received
    December 10, 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.). ADD'L INFO WILL BE PROVIDED UPON THE CONCLUSION OF THE MFR 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 HAD DEVELOPED THIGH BRUISING ON POSTERIOR LEFT LEG THAT RESOLVED W/O TREATMENT (IPC HAD BEEN DISCONTINUED UPON NOTING BRUISING; NO FURTHER INTERVENTION WAS REQUIRED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other