BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCLERAL DEPRESSOR

    MDR report key: 2265607 · Received September 21, 2011

    Report

    Report Number
    MW5022364
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    September 13, 2011
    Report Date
    September 21, 2011
    Manufacturer
    STORZ OPTHALMICS
    Product Code
    HNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE SCLERAL DEPRESSOR THE PHYSICIAN HAD TO RETRIEVE THE SMALL METAL CIRCULAR TIP OF THE INSTRUMENT FROM THE EYE. BOTH PIECES WERE HELD TOGETHER TO DETERMINE THAT THE WHOLE INSTRUMENT WAS RETRIEVED AND INTACT. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCLERAL DEPRESSOR SCLERAL DEPRESSOR HNX STORZ OPTHALMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other