BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTE PRIMUS II

    MDR report key: 844346 · Received April 10, 2007

    Report

    Report Number
    844346
    Event Type
    Malfunction
    Date Received
    April 10, 2007
    Date of Event
    March 15, 2007
    Report Date
    April 10, 2007
    Manufacturer
    BALTIMORE THERAPEUTIC EQUIPMENT CO.
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WY, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS USING THE BTE GRIP TOOL FOR REHABILITATION OF TFCC (TRIANGULAR FIBROCARTILAGE COMPLEX) DEBRIDEMENT. WHILE DOING SO, A SMALL METAL SHARD BECAME IMBEDDED IN HER FINGER. THE PHYSICAL THERAPIST USED A TWEEZER TO REMOVE THE METAL SHARD. NO INFECTION. NO FURTHER COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTE PRIMUS II GRIP STRENGTH TOOL ION BALTIMORE THERAPEUTIC EQUIPMENT CO. PR20 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES