BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUATE STERILE SALINE SOLUTION AEROSOL CAN 12 OZ

    MDR report key: 792846 · Received December 10, 2006

    Report

    Report Number
    MW1041315
    Event Type
    Malfunction
    Date Received
    December 10, 2006
    Date of Event
    December 8, 2005
    Report Date
    December 10, 2006
    Manufacturer
    APPLIED LABORATORIES, INC
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PURCHASED SEVERAL CANS OF EQUATE STERILE SALINE SOLTION FOR CONTACT LENS RECENTLY. ON 12/08/06, MY TEENAGE SON USED ONE OF THE CANS FOR THE FIRST TIME. LATER THAT DAY HIS EYES BECAME IRRITATED. THE NEXT DAY WE SMELLED THE SOLUTION COMING FROM THE CAN. IT HAD A STRONG, MUSTY SMELL. WE CHECKED THE OTHER CANS FROM THE SAME PURCHASE AND THEY ALSO CONTAINED A MUSTY ORDOR. WE COMPARED IT WITH A CAN WE HAD BOUGHT A COUPLE OF MONTHS EARLIER AND THE OLDER CAN DID NOT SMELL MUSTY. OF COURSE, WE ARE NOT GOING TO USE THE MUSTY SMELLING CANS, BUT I WANT TO NOTIFY YOU IN CASE, YOU WANT TO INVESTIGATE. THE NUMBER ON THE BOTTOM OF THE CANS IS "B60901 EXP 08/08." THE CAN STATES IT IS MANUFACTURED BY APPLIED LABORATORIES, INC. OF COLUMBUS, IN 47202. I'LL RETAIN THE CANS UNTIL I HEAR FROM YOU. I DON'T KNOW IF THIS IS SERIOUS, BUT IT SOUNDS AS IF IT COULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE STERILE SALINE SOLUTION AEROSOL CAN 12 OZ * LPN APPLIED LABORATORIES, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *