BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1924739 · Received December 9, 2010

    Report

    Report Number
    1644019-2010-00099
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ALCON - HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED: SHE USED A STRIP OF OCUCEL INSTRUMENT WIPE (POLY VINYL ACETEL) AS AN EYE WICK. SHE BELIEVES SOME OF THIS MATERIAL HAS ENTERED THE EYE (ALTHOUGH SHE CAN'T SEE IT) OF HER PT AND IS CAUSING SIGNIFICANT INFLAMMATION. ADDITIONAL INFO WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OCUCEL INSTRUMENT WIPE