BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PACK

    MDR report key: 2982250 · Received December 17, 2004

    Report

    Report Number
    3002037047-2004-00012
    Event Type
    Malfunction
    Date Received
    December 17, 2004
    Report Date
    November 16, 2004
    Manufacturer
    ALCON - BELGIUM
    Product Code
    KYG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CHECKED CURRENT STOCK IN-HOUSE FOR LOTS 107290 AND 104405; NO PROBLEMS FOUND. NO INDICATION OF PROBLEM IN PRODUCTION RECORD REVIEW. NO OTHER COMPLAINTS FOR THESE FOR THESE LOT IN A TWO YEAR PERIOD. SAMPLES WERE SENT TO THE MSC SUPPLIER ((B)(4)) FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    REPORTER NOTED "FUZZ" DURING SURGERIES OVER TWO WEEKS, BUT COULDN'T IDENTIFY SOURCE. NOW FEELS THEY COME FROM MAYO STAND COVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PACK SURGICAL PACK KYG ALCON - BELGIUM CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA