BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE

    MDR report key: 7302667 · Received February 28, 2018

    Report

    Report Number
    1836161-2018-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    January 30, 2018
    Report Date
    January 30, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FTA
    PMA / PMN Number
    K020304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE ON THE PRODUCT AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A LIGHT HANDLE COVER WAS DISCOVERED WITH PERFORATED PACKAGING ON TWO LOT NUMBERS. THE ITEM WAS NOT IN USE AND NO INJURY/DEATH WAS REPORTED. THE REPORTS WERE FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4) (LOT 133355) AND (B)(4) (LOT 124821).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147010 ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE LIGHT HANDLE FTA ASPEN SURGICAL PRODUCTS, CALEDONIA LT-F01B 133355, 124821

    Patients

    Seq Age Sex Outcome Treatment
    1