BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE MULTIPURPOSE EASY RUB

    MDR report key: 2971731 · Received January 30, 2013

    Report

    Report Number
    3004537773-2013-00006
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ADVANCED MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. FUNCTIONAL EVAL OF THE PRODUCT RETAINED FROM LOT AK01123 WERE PERFORMED; ALL RESULTS WERE WITHIN SPECIFICATION. VISUAL EXAM OF THE PRODUCT RETAINED FROM THE REPORTED LOT WERE PERFORMED; ALL RESULTS WERE WITHIN SPECIFICATION. VISUAL EVAL OF THE RETURNED DEVICE WAS PERFORMED. THE FLIP-TOP CAP SHOWED A PIN HOLE IN THE FRONT SIDE OF THE BOTTLE CAP. FURTHER INSPECTION OF THE HOLE SHOWED THAT THE BOTTLE HAD BEEN SCRATCHED. THE DIRECTION OF THESE SCRATCHES FOES FROM OUTSIDE TO INSIDE. IT APPEARS THAT THE CAP WAS PIERCED BY A NEEDLE. THIS WAS CONFIRMED WHEN WE FOUND SCRATCHES INSIDE THE FLIP TP CAP. IT APPEARS THAT THE UNIT WAS MANIPULATED AFTER IT LEFT THE MANUFACTURING SITE. ALL PERTINENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT HER BOTTLE OF COMPLETE MULTIPURPOSE SOLUTION EASY RUB HAD A SMALL HOLE IN THE CAP AND LEAKED. REPORTER DID NOT USE THE PRODUCT AND RETURNED IT TO THE MFR FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41735 COMPLETE MULTIPURPOSE EASY RUB LPN ADVANCED MEDICAL OPTICS INC AK01123

    Patients

    Seq Age Sex Outcome Treatment
    1