BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ SPAINDE SCLERAL DEPRESSOR

    MDR report key: 2438154 · Received February 1, 2012

    Report

    Report Number
    1920664-2012-00014
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    November 8, 2011
    Report Date
    January 3, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WILL NOT BE RETURNING THE INSTRUMENT FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY CONCERNING THE PATIENT'S OUTCOME. NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    A REPORT FROM THE USER FACILITY REPORTED THE OPHTHALMOLOGIST WAS PERFORMING AN EYE EXAM USING A SCLERAL DEPRESSOR ON A 9 WEEK OLD PREEMIE. A SUB-CONJUNCTIVAL BLEED WAS NOTED. THE TIP OF THE INSTRUMENT WAS NOTED TO HAVE A SHARP BURR. ON CLOSER INSPECTION A HAIRLINE CRACK WAS NOTED ON THE TIP OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ SPAINDE SCLERAL DEPRESSOR SCLERAL DEPRESSOR HNX BAUSCH & LOMB, INC. E5112

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO