BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVA TDC VITRECTOMY PACK GRAVITY INPUT 25G

    MDR report key: 8240325 · Received January 11, 2019

    Report

    Report Number
    1222074-2019-00006
    Event Type
    Injury
    Date Received
    January 11, 2019
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
    Product Code
    QDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE, NO DEFECT IN THE PRODUCT WAS DETECTED (THE PRODUCT WAS NOT RETURNED, BUT A DEFECT IS CONSIDERED HIGHLY UNLIKELY). THE ISSUE IN THIS CASE RELATED TO THE ACCIDENTAL INSERTION OF THE CATHETER INTO THE SUPRACHOROIDAL SPACE, AND SUBSEQUENTLY AN UNINTENTIONAL SUPRACHOROIDAL INFUSION WAS PERFORMED. THIS CASE RELATES TO AN ERROR OF SURGICAL TECHNIQUE, AND NO PRODUCT DEFECT IS SUSPECTED. (B)(4).

    Description of Event or Problem · 1

    SET UP 25G INFUSION TROCAR ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS FOR TUNING. SUPRA-CHOROIDAL INFUSION. MASSIVE CHOROIDAL DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32550 EVA TDC VITRECTOMY PACK GRAVITY INPUT 25G OPHTHALMIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE QDY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA

    Patients

    Seq Age Sex Outcome Treatment
    1