BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 8627595 · Received May 21, 2019

    Report

    Report Number
    1047429-2019-00010
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 21, 2019
    Manufacturer
    LA ADA DE ACUNA, S. DE. R. L. DE C. V.
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY REF: (B)(4), CATARACT PACK THAT INCLUDES THE FOLLOWING COMPONENT: COVER, BACK TABLE 44 X 78, REF: (B)(4) MANUFACTURED BY LA ADA DE ACUNA, S. DE. R. L. DE C. V. (REGISTRATION: (B)(4)). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2019 ORIGINATED BY (B)(4), OR (B)(4), (B)(6) ALLEGING THAT THE BACK TABLE COVER WAS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND CONSEQUENTLY IN PATIENT'S EYES. THE COVER, BACK TABLE 44 X 78 PART WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER PER REF: (B)(4), MANUFACTURER LOT: AC9029081. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421842 HALYARD DRAPE PUI LA ADA DE ACUNA, S. DE. R. L. DE C. V. 42216NS AC9029081

    Patients

    Seq Age Sex Outcome Treatment
    1