BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 1414663 · Received July 8, 2009

    Report

    Report Number
    2618676-2009-00001
    Event Type
    Other
    Date Received
    July 8, 2009
    Date of Event
    June 12, 2009
    Report Date
    July 8, 2009
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE (3) PIECES OF BLADE (B)(4) WITH A "CRUMPLE" CONDITION. AS A RESULT, THE STERILITY WAS COMPROMISED. PRODUCT WAS NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT SHARPTOME FULL HANDLE BEVEL UP HNN SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH 74-1010 M539950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE