BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCED SALT SOLUTION

    MDR report key: 2002836 · Received February 28, 2011

    Report

    Report Number
    9614546-2011-00006
    Event Type
    Injury
    Date Received
    February 28, 2011
    Report Date
    January 29, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT HAVING THE SAMPLE OF THE POTENTIAL DEFECTIVE LABEL IT IS NOT POSSIBLE TO PERFORM AN INVESTIGATION APART FROM THE FORMAL BATCH REVIEW AND RETAIN SAMPLES VERIFICATION. THE REVIEW OF THE BATCH RECORD DID NOT REVEAL ANY DEVIATION OR NON-CONFORMITY RELATED TO THIS COMPLAINT FROM ALL THE CHECKS CARRIED OUT ON THE PRODUCT DURING MANUFACTURING PROCESS. NO ISSUES WERE FOUND ALSO FROM THE REVIEW OF THE RETAINED SAMPLES OF THE INVOLVED BATCH 10E0308. NO OTHER COMPLAINTS WERE RECEIVED FOR BATCH 10E0308 AND NO SIMILAR REPORTS WERE RECEIVED FOR THIS PRODUCT. WE ARE NOT ABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THIS EVENT. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THE BOTTLE FELL FROM THE I.V. POLE WHEN THE SUPPORTING STRAP BROKE AS THE PHACO MACHINE WITH I.V. POLE WAS BEING MOVED BY A MEMBER OF THE O.R. STAFF. BOTTLE STRUCK THE STAFF MEMBER ON THE HEAD CAUSING A MILD CONCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCED SALT SOLUTION BSS KIP ABBOTT MEDICAL OPTICS ENDOSOL 10E0308

    Patients

    Seq Age Sex Outcome Treatment
    1 Other