BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA TDC VITRECTOMY PACK VGPC INPUT 25G

    MDR report key: 8218178 · Received January 4, 2019

    Report

    Report Number
    1222074-2019-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS RETURNED, INITIAL ANALYSIS TO DETERMINE THE NATURE AND ROOT CAUSE OF THE PACKAGING ISSUE IS IN PROGRESS. [(B)(4)].

    Description of Event or Problem · 1

    POSSIBLE PACKAGING INTEGRITY ISSUE WHICH WAS DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9363 EVA TDC VITRECTOMY PACK VGPC INPUT 25G OPHTHALMIC SURGICAL PROCEDURE PACKS AND KITS QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA 8310.25G02 2000398237

    Patients

    Seq Age Sex Outcome Treatment
    1