BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCED SALT SOLUTION

    MDR report key: 2882710 · Received December 20, 2012

    Report

    Report Number
    9614546-2012-00212
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF ENDOSOL BALANCED SALT SOLUTION THAT THE LABEL/HANGER OF THE BOTTLE BROKE OFF. THE BOTTLE NEARLY HIT THE PHYSICIAN BUT HE WAS ABLE TO CATCH IT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCED SALT SOLUTION SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS ENDOSOL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1