BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE COATED BIO-EYE

    MDR report key: 2132619 · Received June 9, 2011

    Report

    Report Number
    MW5020971
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    October 19, 2010
    Report Date
    June 9, 2011
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN URGENT SAFETY NOTIFICATION REPORT DATED (B)(6) 2011, ON COATED BIO-EYE ORBITAL IMPLANT FROM MANUFACTURER, INTEGRATED ORBITAL IMPLANTS INDICATING THAT SPECIFIC LOT NUMBERS WERE NOT LABELED WITH AN EXPIRATION DATE. IOI REPORTED THAT THE SPECIFIC LOT NUMBERS AT OUR FACILITY SHOULD HAVE HAD A (B)(6) 2008 EXPIRATION DATE. ONE IMPLANT, THE HYDROXYAPATITE ORBITAL IMPLANT AND CONFORMER 18MM CAT# I0018C, SERIAL NUMBER (B)(6), LOT NUMBER 36307 WAS IMPLANTED (B)(6) 2010 AFTER THE EXPIRATION DATE GIVEN TO US BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE COATED BIO-EYE HYDROXYAPATITE IMPLANT AND CONFORMER 18MM HPZ INTEGRATED ORBITAL IMPLANTS 36307

    Patients

    Seq Age Sex Outcome Treatment
    1