BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCLING BAND (240 STYLE)

    MDR report key: 145644 · Received January 22, 1998

    Report

    Report Number
    1920664-1998-00025
    Event Type
    Malfunction
    Date Received
    January 22, 1998
    Date of Event
    December 30, 1997
    Report Date
    January 5, 1998
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THESE BANDS STRETCH BUT THEY ARE NOT ELASTIC. THE PROBLEM WAS DISCOVERED DURING SURGERY. A NEW BOX WITH A NEW LOT NUMBER WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLING BAND (240 STYLE) Implant RETINAL DETACHMENT IMPLANT HQX STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO