BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ CIRCLING BAND (240 STYLE)

    MDR report key: 36877 · Received August 30, 1996

    Report

    Report Number
    1920664-1996-00595
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    April 1, 1996
    Report Date
    August 2, 1996
    Manufacturer
    STORZ INSTRUMENT CO
    Product Code
    HQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARIZATION OF CYTOTOXICITY TESTS ARE AS FOLLOWS: SAMPLE E5381-700 LOT 261038345 IDENTIFIED AS "BLUE" AND "PROBLEM": GRADE/REACTIVITY: 0/NONE, CONCLUSION: NOT CYTOTOXIC. SAMPLE E5381-700 LOT 149035276 IDENTIFIED AS "YELLOW" AND "NO PROBLEM": GRADE/REACTIVITY: 1/SLIGHT, CONCLUSION: NOT CYTOTOXIC. SAMPLE E5381-700 PART REPRESENTING CURRENT INVENTORY: GRADE/REACTIVITY: 0/NONE, CONCLUSION: NOT CYTOTOXIC.

    Description of Event or Problem · 1

    SINCE IMPLANTATION OF THESE EXTRA-OCULAR CIRCLING BANDS BEGINNING IN APRIL 1996, FIVE PTS HAVE SUFFERED TREMENDOUS INFLAMMATORY REACTION, RESTRICTED MOBILITY AND EXOPHTHALMOS. THE CIRCLING BANDS WERE EXPLANTED AND THE PTS REIMPLANTED WITH ANOTHER CIRCLING BAND. ON THE SIXTH DAY THERE WAS THE DISAPPEARANCE OF PAIN AND INFLAMMATION. THE CIRCLING BAND WAS EXAMINED IN THE BACTERIOLOGICAL DEPARTMENT. NO INFECTIONS WERE FOUND. THE CIRCLING BANDS BEING USED ARE OF TWO DIFFERENT COLORS: ONE IS BLUE AND THE OTHER HAS A "YELLOW" SHINE. THE BANDS WITH THE BLUE SHINE WERE INVOLVED IN THE REPORTED INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ CIRCLING BAND (240 STYLE) Implant EXTRA OCULAR ORBITAL IMPLANT HQX STORZ INSTRUMENT CO NA 261038345

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R