BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1210734 · Received October 23, 2008

    Report

    Report Number
    3034525-2008-00009
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    February 20, 2007
    Report Date
    March 5, 2007
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SURGERY WAS DONE TO REPLACE A BENT I.M. NAIL. NO X-RAYS OF THE BENT NAIL OR INFO REGARDING THE LOT CODE WAS PROVIDED BY THE HOSP. SIGN REQUESTED FURTHER INFO FROM THE HOSP AND REC'D NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I.M. NAIL STANDARD I.M. NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R