BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 2191813 · Received July 28, 2011

    Report

    Report Number
    1313525-2011-00013
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS DISCOVERED DURING THE INVESTIGATION OF AN INVENTORY DISCREPANCY. THE INVESTIGATION REVEALED THAT ONE PALLET OF BULK PRODUCT BOTTLES WAS INCORRECTLY CARTONED. THIS IS NOT A HEALTH HAZARD CONCERN AS THE PRODUCT IS CARTONED WITH THE APPROPRIATE CONTENT OF LABELING AND IT HAS A WELL ESTABLISHED STABILITY PROFILE PAST THE TWO YEAR EXPIRATION DATE.

    Description of Event or Problem · 1

    RETAILER REPORTED THAT A CONSUMER EXPERIENCED BURNING/STINGING AFTER PRODUCT USE. THIS COMPLAINT IS REPORTED AGAINST A PRODUCT LOT THAT IS BEING RECALLED DUE TO AN INCORRECT EXPIRATION DATE AND LOT CODE LISTING ON THE OUTER CARTON. THE COMPLAINT IS NOT RELATED TO THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB GC1107

    Patients

    Seq Age Sex Outcome Treatment
    1