BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 3092836 · Received May 3, 2013

    Report

    Report Number
    2020664-2013-00022
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOUR SAMPLES RECEIVED WERE VISUALLY AND FUNCTIONALLY TESTED. THEY PASSED THE PRIME TEST WITHIN SPECIFICATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    TUBING PACKS HAVE BEEN REQUESTED TO THE CUSTOMER AND AT THE TIME OF THIS REPORT THEY HAVE NOT BEEN RECEIVED. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO AMO AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO THE TERRITORY MANAGER THAT THEY HAVE TWO INFECTIONS VERY RECENTLY. THEY LATER CORRECTED IT WAS ONLY ONE PATIENT. PATIENT WAS SENT TO A SPECIALIST IN MEMPHIS FOR TREATMENT OF ACUTE ENDOPHTHALMITIS AND DECREASED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194771 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC ABBOTT MEDICAL OPTICS OPO65 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SOVEREIGN COMPACT (SN (B)(4)) AND HEALON GV OVD