BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLIMM FISHTER DIRECTIONAL STROKING PERCUSSOR

    MDR report key: 1770449 · Received July 20, 2010

    Report

    Report Number
    MW5016809
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GENERAL PHYSIOTHERAPY INC.
    Product Code
    BYI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT CLIENT'S HOME TODAY, FATHER REPORTED THAT THE CORD WAS FRAYED IN TWO PLACES TO ELECTRIC PERCUSSOR. CLINICAL MANAGER NOTED EXPOSED WIRES TO CORD, AND IMMEDIATELY TOLD FAMILY THE MACHINE COULD NOT BE USED. MACHINE WAS REMOVED FROM CLIENT'S ROOM AND PLACED IN THE BASEMENT. THERE WAS NO INJURY OR ADVERSE EFFECT TO CLIENT. PRODUCT WAS SAFELY REMOVED FROM CLIENT'S HOME. MD WAS NOTIFIED. DATES OF USE: #1 (B)(6) 2000, #2 (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: MYOTONIC MUSCULAR DYSTROPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLIMM FISHTER DIRECTIONAL STROKING PERCUSSOR ELECTRIC CHEST PERCUSSOR BYI GENERAL PHYSIOTHERAPY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention