BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM PAK

    MDR report key: 2195172 · Received July 15, 2011

    Report

    Report Number
    1644019-2011-00031
    Event Type
    Other
    Date Received
    July 15, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KDD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT RETAINED FIBERS WERE OBSERVED IN THE EYES OF TWO PTS FOLLOWING SURGERY. THE NURSE ALSO STATED THE WECK-CEL SPONGES ARE FALLING OUT OF THE PLASTIC BAGS INSIDE THE CUSTOM PACK PRIOR TO OPENING AND SUSPECTS THE SPONGES COULD BE TRACKING FIBERS FROM THE TABLE COVER. ADD'L INFO FROM THE NURSE INDICATED THE FIBERS ARE ONLY VISIBLE UNDER A MICROSCOPE AND THERE IS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KDD ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other