BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNIFE HANDLE NO 3

    MDR report key: 1525095 · Received November 9, 2009

    Report

    Report Number
    1226348-2009-00302
    Event Type
    Injury
    Date Received
    November 9, 2009
    Date of Event
    August 26, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GDZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCALPEL BLADE DISCONNECTED FROM HANDLE AND REQUIRED EXTRACTION. PHYSICIAN NOTED THIS MIGHT HAVE HAPPENED DUE TO "MORBID OBESITY AND ANTIQUATED NATURE OF THE SCALPEL HANDLE". IT WAS ALSO NOTED THAT THE KNIFE HANDLE WAS VERY OLD. AS A RESULT, THE SURGEON HAD TO MAKE THE INCISION SLIGHTLY LONGER TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE HANDLE NO 3 SCALPEL HANDLE GDZ CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention