BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATARACT CUSTOM DRAPE PACK

    MDR report key: 3893439 · Received June 18, 2014

    Report

    Report Number
    3893439
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    November 4, 2013
    Report Date
    June 18, 2014
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATARACT CUSTOM PACK CONTAINED A FOREIGN SPECK OF SOME MATERIAL. DISCOVERED DURING CASE SET-UP. NEW PACK OBTAINED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358951 CATARACT CUSTOM DRAPE PACK DRAPE, SURGICAL HMT ALCON LABORATORIES, INC * 1503113H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR