BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWISS DOLORCLAST CLASSIC

    MDR report key: 1669989 · Received April 21, 2010

    Report

    Report Number
    3004096429-2010-00002
    Event Type
    Injury
    Date Received
    April 21, 2010
    Report Date
    April 21, 2010
    Manufacturer
    E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
    Product Code
    NBN
    PMA / PMN Number
    PO50004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DOCTOR IS COMPLAINING OF TINNITUS AND A REDUCTION OF HIS HEARING CAPACITY AFTER HAVING TREATED HIS OWN NECK WITH A DOLORCLAST. THE (B) (4) DOLORCLAST IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PTS (B) (6) WITH SYMPTOMS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY (SEE USER MANUAL FB-336/US). ACCORDING TO THE INFO REPORTED: THE DOLORCLAST HAD BEEN USED FOR AN OFF LABELLED APPLICATION. THE DOCTOR SEEMS TO SUFFER FROM BECHTEREV'S DISEASE (ANKYLOSING SPONDYLITIS), WHICH IS AN INFLAMMATORY DISEASE OF THE JOINTS. CURRENTLY, THERE IS NO EVIDENCE OF A LINK BETWEEN THE REPORTED SYMPTOMS AND THE DEVICE. WE CONTINUE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWISS DOLORCLAST CLASSIC SHOCK WAVE GENERATOR NBN E.M.S. ELECTRO MEDICAL SYSTEMS S.A. FT-126W UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other