BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON EXCEL

    MDR report key: 2389900 · Received December 15, 2011

    Report

    Report Number
    1000381138-2011-00034
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 18, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION# (B)(4)) ON BEHALF OF THE MFR ARJOHUNTLEIGH, A BRANCH OF ARJO LTD., MED (B)(4) (REGISTRATION# (B)(4)). IT HAS BEEN CONFIRMED THAT THE PT WAS TREATED FOR THE CONDITION AND DISCHARGED FROM THE HOSPITAL WITHOUT FURTHER COMPLICATIONS. SIMILAR SITUATION TO MEDWATCH REPORT# 100381138-2011-00033. THE INFO CONTAINED IN THIS INITIAL REPORT IS BASED UPON THE INFO PROVIDED TO THE MFR BY REPS OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    ORTHOPEDIC SURGERY PT HAD THE FLOWTRON EXCEL AC550 IN USE WITH APPROPRIATE LEG COMPRESSION GARMENTS; SUBSEQUENTLY DEVELOPED A DVT AND PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXCEL DVT JOW ARJOHUNTLEIGH 247001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention