BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLECTION

    MDR report key: 2842876 · Received November 21, 2012

    Report

    Report Number
    1020279-2012-00637
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BROOKS MANUFACTURING SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LINER WAS CHECKED DIMENSIONALLY. THERE WERE FEATURES FOUND TO BE OUT OF PRINT SPECIFICATION. THESE CONDITIONS ARE COMMONLY SEEN AFTER THE PART WAS USED TO MAKE MULTIPLE INSERTION ATTEMPTS AND WILL PHYSICALLY CHANGE THE PART SIZE. A VISUAL INVESTIGATION NOTES SCRATCHES ARE VISIBLE ON THE RETURNED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY WAS DELAYED DUE TO THE LINER NOT SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLECTION LINER JDH BROOKS MANUFACTURING SITE OR71742846 12AM13128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization