BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE TIRE IMPLANT 287-STYLE FOR RETINAL DETACHMENT

    MDR report key: 63970 · Received January 10, 1997

    Report

    Report Number
    1920664-1997-00021
    Event Type
    Malfunction
    Date Received
    January 10, 1997
    Date of Event
    December 13, 1996
    Report Date
    December 13, 1996
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN THE PACKAGE WAS OPENED FOR USED DURING AN OPHTHALMIC PROCEDURE, THERE WAS NO SILICONE TIRE ENCLOSED; THE PACKAGE WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE TIRE IMPLANT 287-STYLE FOR RETINAL DETACHMENT Implant RETINAL DETACHMENT IMPLANT HQX STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO