BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN

    MDR report key: 1060183 · Received April 30, 2008

    Report

    Report Number
    1610287-2008-00009
    Event Type
    Injury
    Date Received
    April 30, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    SCOTT MEDICAL
    Product Code
    LPO
    PMA / PMN Number
    p900067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN RETINAL STABILIZING ADJUNCT LPO SCOTT MEDICAL NA 623308

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention