BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCLING BAND (240 STYLE)

    MDR report key: 137983 · Received December 11, 1997

    Report

    Report Number
    1920664-1997-00541
    Event Type
    Malfunction
    Date Received
    December 11, 1997
    Date of Event
    November 8, 1997
    Report Date
    November 12, 1997
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE RECALL WAS INITIATED FOR THIS PRODUCT ON 1/6/1998.

    Description of Event or Problem · 1

    TWO OF THESE CIRCLING BANDS BROKE DURING AN OPHTHALMIC PROCEDURE. ANOTHER TYPE OF BAND WAS USED FOR THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY.

    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