BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL

    MDR report key: 2987575 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00089
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    October 30, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVAL.

    Description of Event or Problem · 1

    LIGHT HANDLE COVER FELL OFF THE LIGHT HANDLE AND INTO THE PT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78813 ASPEN SURGICAL LIGHT HANDLE COVER FTA ASPEN SURGICAL PRODUCTS, INC. 12138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other