BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOLORCLAST

    MDR report key: 1482200 · Received September 16, 2009

    Report

    Report Number
    3004096429-2009-00001
    Event Type
    Injury
    Date Received
    September 16, 2009
    Report Date
    September 15, 2009
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    NBN
    PMA / PMN Number
    PO5004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOLORCLAST IS AN EXTRA CORPOREAL SHOCK WAVE DEVICE INTENDED FOR USE IN TREATING SOFT TISSUE ORTHOPEDIC DISEASES. DOLORCLAST IS INTENDED FOR TREATMENT OF CHRONIC PROXIMALPLANTAR FASCIITIS.

    Description of Event or Problem · 1

    INAPPROPRIATE USE OF DOLORCLAST ON PT WRIST WITH IRREVERSIBLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOLORCLAST SHOCKWAVE GENERATOR FOR PAIN RELIEF NBN E.M.S. ELECTRO MEDICAL SYSTEMS S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability