BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE STRAIGHT

    MDR report key: 1896073 · Received November 10, 2010

    Report

    Report Number
    1219602-2010-00278
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 7, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    BLADE HAS METAL SHAVINGS; AND IT LEFT RESIDUE ON THE PATIENT. THEY WANTED TO HANG ON TO THE PRODUCT AND TEST IT THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE STRAIGHT INCISOR PLUS,5.5MM,EP-1,DSPL BLADE NBH SMITH & NEPHEW ENDOSCOPY 7205459 20144366

    Patients

    Seq Age Sex Outcome Treatment
    1