BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUTURA SAFETY SCALPEL

    MDR report key: 698875 · Received September 30, 2005

    Report

    Report Number
    1832816-2005-00030
    Event Type
    Malfunction
    Date Received
    September 30, 2005
    Date of Event
    September 9, 2005
    Report Date
    September 29, 2005
    Manufacturer
    FUTURA MED. PROD, KAKKANAD, KOCHI, INDIA, OWNED BY HYPOGUARD USA, INC.
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BLADE DOES NOT RETRACT FULLY INTO SCALPEL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUTURA SAFETY SCALPEL SAFETY SCALPEL GDX FUTURA MED. PROD, KAKKANAD, KOCHI, INDIA, OWNED BY HYPOGUARD USA, INC. 68001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *