BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCLING BAND 240-STYLE 2.5

    MDR report key: 143704 · Received January 9, 1998

    Report

    Report Number
    1920664-1998-00006
    Event Type
    Malfunction
    Date Received
    January 9, 1998
    Date of Event
    December 10, 1997
    Report Date
    December 10, 1997
    Manufacturer
    STORZ INSTRUMENT COMPANY
    Product Code
    HQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER ONE OF THESE BANDS HAD BEEN IMPLANTED, THE DR NOTICED IT APPEARED CRACKED. HE REMOVED THE BAND AND REPLACED IT WITH ANOTHER ONE. THERE WERE NO PT PROBLEMS. THE BAND WAS DISPOSED OF. THERE IS NO PRODUCT TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLING BAND 240-STYLE 2.5 Implant IMPLANT FOR RETINAL DETACHMENT SURGERY HQX STORZ INSTRUMENT COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO