BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPAIDE PEDIATRIC SCLERAL DEPRESSOR

    MDR report key: 2383076 · Received December 8, 2011

    Report

    Report Number
    2383076
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 28, 2011
    Manufacturer
    BAUSCH & LOMB, STORZ OPHTHALMICS
    Product Code
    HNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE OPHTHALOMOLOGIST WAS PERFORMING AN EYE EXAM USING A SCLERAL DEPRESSOR ON A 9 WEEK OLD PREMIE. A SUBCONJUNCTIVAL BLEED WAS NOTED. THE TIP OF THE INSTRUMENT WAS NOTED TO HAVE A SHARP BURR. ON CLOSER INSPECTION A HAIRLINE CRACK WAS NOTED AT THE TIP OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPAIDE PEDIATRIC SCLERAL DEPRESSOR SCLERAL DEPRESSOR HNX BAUSCH & LOMB, STORZ OPHTHALMICS E5112 *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 WK