BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 1937615 · Received December 20, 2010

    Report

    Report Number
    1313525-2010-00028
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS DISCARDED BY THE RETAILER. A REVIEW OF THE LOT BATCH RECORDS AND CHEMICAL TESTING OF THE RETAIN SAMPLE SHOWED ALL REQUIREMENTS WERE MET.

    Description of Event or Problem · 1

    RETAILER REPORTED THAT A CONSUMER EXPERIENCED IRRITATION, VISITED AN URGENT CARE AND WAS TREATED. CONSUMER FOLLOWED UP WITH EYE DOCTOR WHO DIAGNOSED AND TREATED FOR CHEMICAL BURNS. EVENT WAS CONFIRMED WITH THE EYE DOCTOR WHO STATED THE SOURCE OF THE CONDITION WAS UNK. CONSUMER HAS RECOVERED. THIS COMPLAINT IS RECORDED AGAINST A PRODUCT LOT THAT IS BEING RECALLED FOR A REPORTED POTENTIAL COMPROMISED PACKAGE STERILITY CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH + LOMB GH0078

    Patients

    Seq Age Sex Outcome Treatment
    1