BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 8764654 · Received July 5, 2019

    Report

    Report Number
    1047429-2019-00014
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 5, 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 INC. IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY REF: NHJV0014-07, CATARACT PACK PIGGYBACK THAT INCLUDES THE FOLLOWING COMPONENT: COVER, BACK TABLE 44 X 78, REF: 42216NS MANUFACTURED BY LA ADA DE ACUNA, S. DE. R. L. DE C. V. (REGISTRATION: 3005997949). AVID MEDICAL RECEIVED A COMPLAINT ON 06/07/19 REPORTED BY O&M HALYARD. THE COMPLAINT HOWEVER WAS ORIGINATED BY (B)(6) ALLEGING THAT THE BACK TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND CONSEQUENTLY IN PATIENT'S EYES. THE COMPLAINT COMPONENT WAS NOT AVAILABLE FOR EVALUATION PER COMPLAINANT. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER FOR REF: 42216NS, MANUFACTURER LOT: AC9029081. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558192 HALYARD DRAPE PUI LA ADA DE ACUNA, S. DE. R. L. DE C. V. 42216NS AC9029081

    Patients

    Seq Age Sex Outcome Treatment
    1