BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE SLEEVE

    MDR report key: 973781 · Received December 26, 2007

    Report

    Report Number
    2027377-2007-00004
    Event Type
    Injury
    Date Received
    December 26, 2007
    Date of Event
    December 11, 2007
    Report Date
    December 5, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION NECESSITATING SURGERY 10 YEARS POST-OPERATIVELY IS AN UNUSUAL OCCURRENCE. INVESTIGATION OF THE EXPLANTED PLASTIC SLEEVE FOUND NO REASON FOR INFECTION NOR ANY DEVICE ISSUE. NOTE: THE PLASTIC SLEEVE IS NO LONGER SOLD. EVALUATION SUMMARY: THE RETURNED DEVICE WAS EXAMINED VISUALLY AND PHOTOGRAPHICALLY AND NO ISSUES WERE IDENTIFIED. SURGEON CONDUCTED PATHOLOGY EVALUATION AND CONFIRMED INFECTION.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED, THAT PT RECEIVED ORBITAL IMPLANT AND PLASTIC SLEEVE "OVER 10 YEARS AGO". PT RECENTLY PRESENTED WITH INFECTION AND PROTRUSION OF THE PLASTIC SLEEVE. PHYSICIAN ATTRIBUTES INFECTION TO THE PLASTIC SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-EYE SLEEVE MOTILITY SLEEVE HPZ INTEGRATED ORBITAL IMPLANTS I00001

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention