BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL

    MDR report key: 2987431 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00064
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    November 16, 2011
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    THE ADAPTOR FELL OUT DURING A PROCEDURE AND STRUCK THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77970 ASPEN SURGICAL LIGHT HANDLE ADAPTOR FTA ASPEN SURGICAL PRODUCTS, INC. 2011-08-15

    Patients

    Seq Age Sex Outcome Treatment
    1 Other