BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER EPOS ULTRA

    MDR report key: 486433 · Received September 23, 2003

    Report

    Report Number
    9611388-2003-00001
    Event Type
    Injury
    Date Received
    September 23, 2003
    Date of Event
    April 30, 2003
    Report Date
    September 22, 2003
    Manufacturer
    DORNIER MEDTECH AMERICA, INC
    Product Code
    NBN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED SWELLING AND SKIN NECROSIS ON LEFT FOOT DURING AN "OFF-LABEL" ACHILLES TENDONITIS PROCEDURE. PHYSICIAN USED LOCAL ANESTHETIC MARCAINE WITH EPINEPHRINE CAUSING RESTRICTION OF BLOOD FLOW AT TREATMENT SITE. ALSO, PT APPEARED TO HAVE SEVERE VENOUS INSUFFICIENCY PROBLEMS IN BOTH FEET WHICH SHOULD HAVE PRECLUDED THE PT FROM TREATMENT. EPOS ULTRA DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER EPOS ULTRA ESWT NBN DORNIER MEDTECH AMERICA, INC EPOS ULTRA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention